Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT02669667
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+44 (0)1223 898263', 'title': 'Rene van der Merwe', 'organization': 'MedImmune'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the start of study drug administration upto Day 240', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infusion site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infusion site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infusion site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myalgia intercostal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'TESAEs', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included participants who received any study drug and summarized according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'TEAEs observed in participants with clinically significant ECG abnormalities were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included participants who received any study drug and summarized according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Signs Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included participants who received any study drug and summarized according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Physical Examination Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'Adverse events observed in participants with clinically significant physical abnormalities were assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included participants who received any study drug and summarized according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'title': 'Liver function test increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Transaminases increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included participants who received any study drug and summarized according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs Related to Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'title': 'Infusion site bruising', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Infusion site erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Infusion site pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection site bruising', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection site haemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection site induration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection site pruritus', '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'}]}]}, {'title': 'Injection site warmth', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included participants who received any study drug and summarized according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG004', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG005', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.01', 'spread': 'NA', 'comment': 'Only 2 out of 4 participants had sufficient elimination data for calculating those PK parameter in Cohort 1. Standard deviation of the mean was not provided when having \\<=2 parameter values.', 'groupId': 'OG000'}, {'value': '68.8', 'spread': '47.3', 'groupId': 'OG001'}, {'value': '179', 'spread': '105', 'groupId': 'OG002'}, {'value': '264', 'spread': '159', 'groupId': 'OG003'}, {'value': '668', 'spread': '132', 'groupId': 'OG004'}, {'value': '1440', 'spread': '126', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314.', 'unitOfMeasure': 'µg*d/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG004', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG005', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.94', 'spread': 'NA', 'comment': 'Only 2 out of 4 participants had sufficient elimination data for calculating those PK parameter in Cohort 1. Standard deviation of the mean was not provided when having \\<=2 parameter values.', 'groupId': 'OG000'}, {'value': '68.6', 'spread': '47.3', 'groupId': 'OG001'}, {'value': '178', 'spread': '105', 'groupId': 'OG002'}, {'value': '264', 'spread': '159', 'groupId': 'OG003'}, {'value': '667', 'spread': '132', 'groupId': 'OG004'}, {'value': '1439', 'spread': '126', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314.', 'unitOfMeasure': 'μg*d/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG004', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG005', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.425', 'spread': '0.367', 'groupId': 'OG000'}, {'value': '5.44', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '5.63', 'groupId': 'OG002'}, {'value': '14.1', 'spread': '8.87', 'groupId': 'OG003'}, {'value': '79.0', 'spread': '14.8', 'groupId': 'OG004'}, {'value': '108', 'spread': '9.99', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'The maximum observed serum drug concentration of MEDI9314.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG004', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG005', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '3.99', 'upperLimit': '4.00'}, {'value': '8.07', 'groupId': 'OG001', 'lowerLimit': '2.99', 'upperLimit': '9.03'}, {'value': '5.52', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '9.13'}, {'value': '5.51', 'groupId': 'OG003', 'lowerLimit': '3.99', 'upperLimit': '9.08'}, {'value': '0.04', 'groupId': 'OG004', 'lowerLimit': '0.04', 'upperLimit': '0.04'}, {'value': '0.04', 'groupId': 'OG005', 'lowerLimit': '0.04', 'upperLimit': '0.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'The time to maximum observed serum drug concentration of MEDI9314.', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters.'}, {'type': 'SECONDARY', 'title': 'Terminal Phase Elimination Half-life (t1/2) of MEDI9314', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG004', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG005', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': 'NA', 'comment': 'Only 2 out of 4 participants had sufficient elimination data for calculating those PK parameter in Cohort 1. Standard deviation of the mean was not provided when having \\<=2 parameter values.', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '0.685', 'groupId': 'OG001'}, {'value': '4.72', 'spread': '0.998', 'groupId': 'OG002'}, {'value': '5.03', 'spread': '1.13', 'groupId': 'OG003'}, {'value': '7.31', 'spread': '1.29', 'groupId': 'OG004'}, {'value': '8.95', 'spread': '1.14', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'Terminal phase elimination half-life of MEDI9314', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of MEDI9314', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG004', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG005', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21.495', 'spread': '14.790', 'groupId': 'OG000'}, {'value': '9.770', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '22.577', 'spread': '31.370', 'groupId': 'OG002'}, {'value': '9.770', 'spread': '0.000', 'groupId': 'OG003'}, {'value': '9.770', 'spread': '0.000', 'groupId': 'OG004'}, {'value': '9.770', 'spread': '0.000', 'groupId': 'OG005'}]}]}, {'title': 'Day 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '23.432', 'spread': '20.738', 'groupId': 'OG000'}, {'value': '9.770', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '9.770', 'spread': '0.000', 'groupId': 'OG002'}, {'value': '13.167', 'spread': '8.320', 'groupId': 'OG003'}, {'value': '9.770', 'spread': '0.000', 'groupId': 'OG004'}, {'value': '14.573', 'spread': '11.766', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 [predose]) and Day 240', 'description': 'Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Positive for Anti-Drug Antibodies to MEDI9314', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'OG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'OG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'classes': [{'title': 'Baseline ADA positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Day 240- ADA positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1 [predose]) and Day 240', 'description': 'Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included participants who received any study drug and summarized according to the treatment they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'FG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'FG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'FG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'FG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'FG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'FG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'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': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted from 18Feb2016 to 12Jun2017 in United States and United Kingdom.', 'preAssignmentDetails': 'A total of 124 participants were enrolled in the study; of which 80 participants were screen failures. Forty-four participants were randomized to MEDI9314 or placebo" in 7 treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '44', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.'}, {'id': 'BG001', 'title': 'Cohort 1', 'description': 'Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.'}, {'id': 'BG002', 'title': 'Cohort 2', 'description': 'Participants received a single SC injection of MEDI9314 150 mg on Day 1.'}, {'id': 'BG003', 'title': 'Cohort 3', 'description': 'Participants received a single SC injection of MEDI9314 300 mg on Day 1.'}, {'id': 'BG004', 'title': 'Cohort 4', 'description': 'Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1'}, {'id': 'BG005', 'title': 'Cohort 5', 'description': 'Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.'}, {'id': 'BG006', 'title': 'Cohort 6', 'description': 'Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '32.0', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '5.1', 'groupId': 'BG002'}, {'value': '32.0', 'spread': '8.6', 'groupId': 'BG003'}, {'value': '35.0', 'spread': '5.3', 'groupId': 'BG004'}, {'value': '31.2', 'spread': '8.2', 'groupId': 'BG005'}, {'value': '36.0', 'spread': '10.5', 'groupId': 'BG006'}, {'value': '33.0', 'spread': '8.7', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'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'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '44', 'groupId': 'BG007'}]}]}], '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': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}]}, {'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'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}]}, {'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': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The As-treated population included participants who received any study drug and summarized according to the treatment they actually received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2016-01-20', 'resultsFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-13', 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.'}, {'measure': 'Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'TEAEs observed in participants with clinically significant ECG abnormalities were reported.'}, {'measure': 'Number of Participants With Vital Signs Abnormalities Reported as TEAEs', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.'}, {'measure': 'Number of Participants With Physical Examination Abnormalities Reported as TEAEs', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'Adverse events observed in participants with clinically significant physical abnormalities were assessed.'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.'}, {'measure': 'Number of Participants With TEAEs Related to Injection Site Reactions', 'timeFrame': 'From the start of study drug administration upto Day 240', 'description': 'Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314.'}, {'measure': 'Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast)', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314.'}, {'measure': 'Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'The maximum observed serum drug concentration of MEDI9314.'}, {'measure': 'Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'The time to maximum observed serum drug concentration of MEDI9314.'}, {'measure': 'Terminal Phase Elimination Half-life (t1/2) of MEDI9314', 'timeFrame': 'Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240', 'description': 'Terminal phase elimination half-life of MEDI9314'}, {'measure': 'Serum Concentrations of MEDI9314', 'timeFrame': 'Baseline (Day 1 [predose]) and Day 240', 'description': 'Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed.'}, {'measure': 'Number of Participants Positive for Anti-Drug Antibodies to MEDI9314', 'timeFrame': 'Baseline (Day 1 [predose]) and Day 240', 'description': 'Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MEDI9314', 'Safety', 'Tolerability', 'Pharmacokinetics', 'Immunogenicity'], 'conditions': ['Safety', 'Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects', 'detailedDescription': 'This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written informed consent.\n2. Age 18 through 50 years at the time of screening.\n3. Female subjects must be of non-childbearing potential.\n4. Nonsterilized males who are sexually active with a female partner of childbearing potential must use condom and spermicide.\n5. Body mass index of 19.0 through 32.0 kg/m2 at screening.\n6. No clinically significant abnormality on the basis of medical/medication history or physical examination.\n7. Negative drugs of abuse (DOA).\n8. Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.\n9. For the Japanese Cohort, both of the subject's parents and both sets of grandparents must be Japanese.\n\nExclusion Criteria:\n\n1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n2. Concurrent enrollment in another clinical study involving any treatment.\n3. Individuals who are legally institutionalized.\n4. Receipt of \\> 2 marketed or investigational biologic agents.\n5. Receipt of an investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer.\n6. Receipt of any investigational non biologic agent within 3 months or 5 half lives prior to screening, whichever is longer.\n7. Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half lives of Day 1, whichever is longer, unless in the opinion of the investigator and medical monitor the medication will not interfere with the study procedures or compromise subject safety.\n8. Known history of allergy or reaction to any component of the investigational product formulation.\n9. History of anaphylaxis following any biologic therapy.\n10. Any clinically relevant abnormal findings in physical examination ECG, vital signs, and laboratory parameters.\n11. Positive tuberculosis (TB) test (QuantiFERON®-TB Gold In-tube).\n12. Positive hepatitis B surface antigen, hepatitis C virus antibody or HIV test at screening.\n13. Receipt of live attenuated vaccines 30 days prior to the date of screening.\n14. Where donation of blood or blood products was in excess of 500 mL within an 8-week period in the 3 months prior to screening."}, 'identificationModule': {'nctId': 'NCT02669667', 'briefTitle': 'Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 1a Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI9314 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'D4361C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'single dose of MEDI9314 or placebo', 'interventionNames': ['Drug: MEDI9314', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'single dose of MEDI9314 or placebo', 'interventionNames': ['Drug: MEDI9314', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'single dose of MEDI9314 or placebo', 'interventionNames': ['Drug: MEDI9314', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'single dose of MEDI9314 or placebo', 'interventionNames': ['Drug: MEDI9314', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Japanese Cohort', 'description': 'single dose of MEDI9314 or placebo', 'interventionNames': ['Drug: MEDI9314', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'single dose of MEDI9314 or placebo', 'interventionNames': ['Drug: MEDI9314', 'Drug: placebo']}], 'interventions': [{'name': 'MEDI9314', 'type': 'DRUG', 'description': 'single dose of MEDI9314', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Japanese Cohort']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'single dose of placebo', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Japanese Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Muna Albayaty, MBChB, FFPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel'}, {'name': 'Hakop Gevorkyan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}