Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 2:38 AM
Study NCT ID:
NCT04507256
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2020-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000714168', 'term': 'cilgavimab and tixagevimab drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Head', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)', 'eventGroups': [{'id': 'EG000', 'title': 'Pooled Placebo', 'description': 'Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nail infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Energy increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Heavy menstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Myxoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Tooth repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.'}, {'id': 'OG001', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG004', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG005', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Any AE with outcome of death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any SAE (including events with outcome of death)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any AE leading to discontinuation of Investigational Medicinal Product (IMP)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any AE leading to dose interruption', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Ant AE leading to dose reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any AE leading to withdrawal from the study', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)', 'description': 'The safety and tolerability of AZD7442 administered IV or IM to healthy adult participants 18 to 55 years of age was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were randomized and received any amount of AZD7442.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration (Cmax) of AZD7442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG001', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG004', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '16.52', 'spread': '35.56', 'groupId': 'OG000'}, {'value': '53.71', 'spread': '10.24', 'groupId': 'OG001'}, {'value': '162.2', 'spread': '11.31', 'groupId': 'OG002'}, {'value': '505.8', 'spread': '10.54', 'groupId': 'OG003'}, {'value': '447.8', 'spread': '8.980', 'groupId': 'OG004'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '15.27', 'spread': '38.53', 'groupId': 'OG000'}, {'value': '51.69', 'spread': '12.31', 'groupId': 'OG001'}, {'value': '154.3', 'spread': '14.66', 'groupId': 'OG002'}, {'value': '465.5', 'spread': '11.09', 'groupId': 'OG003'}, {'value': '419.3', 'spread': '11.62', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose Cmax of AZD7442 and of the individual monoclonal antibodies (mAbs) in serum were evaluated.', 'unitOfMeasure': 'μg/mL (microgram per milliliter)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Serum Concentration (Tmax) of AZD7442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG001', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG004', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '13.96', 'groupId': 'OG000', 'lowerLimit': '3.05', 'upperLimit': '29.99'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.33'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.05'}, {'value': '0.10', 'groupId': 'OG003', 'lowerLimit': '0.06', 'upperLimit': '0.13'}, {'value': '0.05', 'groupId': 'OG004', 'lowerLimit': '0.05', 'upperLimit': '0.05'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '13.98', 'groupId': 'OG000', 'lowerLimit': '3.05', 'upperLimit': '60.23'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.96'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.34'}, {'value': '0.06', 'groupId': 'OG003', 'lowerLimit': '0.06', 'upperLimit': '0.33'}, {'value': '0.05', 'groupId': 'OG004', 'lowerLimit': '0.05', 'upperLimit': '0.33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose tmax of AZD7442 and of the individual mAbs in serum was evaluated', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (t½λz) of AZD7442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG001', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG004', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '87.76', 'spread': '14.56', 'groupId': 'OG000'}, {'value': '86.97', 'spread': '5.195', 'groupId': 'OG001'}, {'value': '92.38', 'spread': '17.23', 'groupId': 'OG002'}, {'value': '91.27', 'spread': '7.827', 'groupId': 'OG003'}, {'value': '95.33', 'spread': '11.06', 'groupId': 'OG004'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '79.78', 'spread': '9.649', 'groupId': 'OG000'}, {'value': '91.08', 'spread': '9.152', 'groupId': 'OG001'}, {'value': '83.05', 'spread': '16.22', 'groupId': 'OG002'}, {'value': '88.52', 'spread': '9.086', 'groupId': 'OG003'}, {'value': '87.17', 'spread': '10.78', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose t½λz of AZD7442 and of the individual mAbs in serum was evaluated.', 'unitOfMeasure': 'Day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG001', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG004', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '2367', 'spread': '28.92', 'groupId': 'OG000'}, {'value': '3467', 'spread': '13.20', 'groupId': 'OG001'}, {'value': '9237', 'spread': '11.75', 'groupId': 'OG002'}, {'value': '29800', 'spread': '9.799', 'groupId': 'OG003'}, {'value': '29380', 'spread': '10.81', 'groupId': 'OG004'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '2018', 'spread': '30.98', 'groupId': 'OG000'}, {'value': '3085', 'spread': '13.01', 'groupId': 'OG001'}, {'value': '9245', 'spread': '11.22', 'groupId': 'OG002'}, {'value': '28160', 'spread': '10.85', 'groupId': 'OG003'}, {'value': '28210', 'spread': '11.21', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose AUClast of AZD7442 and of the individual mAbs in serum was evaluated.', 'unitOfMeasure': 'day*μg/mL (microgram per milliliter)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG001', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG004', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '2526', 'spread': '29.75', 'groupId': 'OG000'}, {'value': '3677', 'spread': '13.75', 'groupId': 'OG001'}, {'value': '9893', 'spread': '12.58', 'groupId': 'OG002'}, {'value': '31850', 'spread': '10.85', 'groupId': 'OG003'}, {'value': '31850', 'spread': '11.89', 'groupId': 'OG004'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '2130', 'spread': '31.25', 'groupId': 'OG000'}, {'value': '3276', 'spread': '14.17', 'groupId': 'OG001'}, {'value': '9712', 'spread': '11.69', 'groupId': 'OG002'}, {'value': '29860', 'spread': '11.71', 'groupId': 'OG003'}, {'value': '30030', 'spread': '11.82', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric mean AUCinf', 'paramValue': '68.69', 'estimateComment': 'The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895.', 'groupDescription': 'Bioavailability of AZD8895 at the end of study (Day 361)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Bioavailability'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric mean AUCinf', 'paramValue': '65.02', 'estimateComment': 'The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD1061.', 'groupDescription': 'Bioavailability of AZD1061 at the end of study (Day 361)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Bioavailability'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose AUCinf of AZD7442 and of the individual mAbs in serum was evaluated. The bioavailability (F) of AZD7442 Dose 1 administered by IM was calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895 and mAb AZD1061 is also presented.', 'unitOfMeasure': 'day*ug/mL (microgram per milliliter)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Systemic Clearance (CL) of AZD7442 IV Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG001', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '0.04113', 'spread': '0.005411', 'groupId': 'OG000'}, {'value': '0.05090', 'spread': '0.006510', 'groupId': 'OG001'}, {'value': '0.04736', 'spread': '0.005317', 'groupId': 'OG002'}, {'value': '0.04740', 'spread': '0.005661', 'groupId': 'OG003'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '0.04618', 'spread': '0.006162', 'groupId': 'OG000'}, {'value': '0.05180', 'spread': '0.006260', 'groupId': 'OG001'}, {'value': '0.05055', 'spread': '0.006086', 'groupId': 'OG002'}, {'value': '0.05026', 'spread': '0.006036', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose CL of AZD7442 and of the individual mAbs in serum was evaluated.', 'unitOfMeasure': 'L (Litre)/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the statistical analysis plan (SAP) and clinical study protocol (CSP) to report CL for only arms receiving IV infusion.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Clearance (CL/F) of AZD7442 IM Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '0.06174', 'spread': '0.01857', 'groupId': 'OG000'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '0.07383', 'spread': '0.02733', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose CL/F of AZD7442 and of the individual mAbs in serum was evaluated.', 'unitOfMeasure': 'L (Litre)/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the SAP and CSP to report CL/F for only arm receiving IM injection.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG001', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG004', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '7.771', 'spread': '2.152', 'groupId': 'OG000'}, {'value': '5.150', 'spread': '0.5804', 'groupId': 'OG001'}, {'value': '6.814', 'spread': '1.065', 'groupId': 'OG002'}, {'value': '6.227', 'spread': '0.5926', 'groupId': 'OG003'}, {'value': '6.514', 'spread': '0.7232', 'groupId': 'OG004'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '8.471', 'spread': '2.832', 'groupId': 'OG000'}, {'value': '6.042', 'spread': '0.5914', 'groupId': 'OG001'}, {'value': '6.241', 'spread': '0.9723', 'groupId': 'OG002'}, {'value': '6.449', 'spread': '0.6920', 'groupId': 'OG003'}, {'value': '6.324', 'spread': '0.7784', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose Vz/F of AZD7442 and of the individual mAbs in serum was evaluated.', 'unitOfMeasure': 'L (Litre)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG001', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '5.074', 'spread': '0.4766', 'groupId': 'OG000'}, {'value': '6.520', 'spread': '0.9739', 'groupId': 'OG001'}, {'value': '6.118', 'spread': '0.5983', 'groupId': 'OG002'}, {'value': '6.373', 'spread': '0.6854', 'groupId': 'OG003'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '5.687', 'spread': '0.4691', 'groupId': 'OG000'}, {'value': '6.020', 'spread': '0.8755', 'groupId': 'OG001'}, {'value': '6.311', 'spread': '0.6722', 'groupId': 'OG002'}, {'value': '6.286', 'spread': '0.7465', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose Vss of AZD7442 and of the individual mAbs in serum was evaluated.', 'unitOfMeasure': 'L (Litre)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the SAP and CSP to report Vss for only arms receiving IV infusion.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.'}, {'id': 'OG001', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG002', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'OG003', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'OG004', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'OG005', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'classes': [{'title': 'AZD8895', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'AZD1061', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 361 (Post dose)', 'description': 'The ADA response to AZD7442 in serum was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were randomized and received any amount of AZD7442.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pooled Placebo', 'description': 'Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.'}, {'id': 'FG001', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'FG002', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'FG003', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'FG004', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'FG005', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 60 healthy participants were enrolled at a single study center in the United Kingdom (UK) from 18 August 2020 to 19 0ctober 2021.', 'preAssignmentDetails': 'Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. A washout period was not included in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Pooled Placebo', 'description': 'Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.'}, {'id': 'BG001', 'title': 'AZD7442 300 mg, IM', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'BG002', 'title': 'AZD7442 300 mg, IV', 'description': 'Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.'}, {'id': 'BG003', 'title': 'AZD7442 1000 mg, IV', 'description': 'Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.'}, {'id': 'BG004', 'title': 'AZD7442 3000 mg, IV', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.'}, {'id': 'BG005', 'title': 'AZD7442 3000 mg, IV Co-administered', 'description': 'Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '11.45', 'groupId': 'BG000'}, {'value': '41.9', 'spread': '6.51', 'groupId': 'BG001'}, {'value': '40.7', 'spread': '7.83', 'groupId': 'BG002'}, {'value': '38.9', 'spread': '8.86', 'groupId': 'BG003'}, {'value': '35.8', 'spread': '9.44', 'groupId': 'BG004'}, {'value': '39.6', 'spread': '9.30', 'groupId': 'BG005'}, {'value': '39.17', 'spread': '8.86', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}, {'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'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The randomized set consisted of all participants randomized into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-19', 'size': 15473652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-15T10:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The study will be blinded for all placebo controlled dose groups, ie, the Principal Investigator (PI), all clinical staff involved in the clinical study, the participants, and the study monitor will remain blinded, unless safety concerns or a regulatory requirement necessitate unblinding.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2020-08-07', 'resultsFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-17', 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious AEs', 'timeFrame': 'From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)', 'description': 'The safety and tolerability of AZD7442 administered IV or IM to healthy adult participants 18 to 55 years of age was evaluated.'}], 'secondaryOutcomes': [{'measure': 'Maximum Serum Concentration (Cmax) of AZD7442', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose Cmax of AZD7442 and of the individual monoclonal antibodies (mAbs) in serum were evaluated.'}, {'measure': 'Time to Reach Maximum Serum Concentration (Tmax) of AZD7442', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose tmax of AZD7442 and of the individual mAbs in serum was evaluated'}, {'measure': 'Terminal Elimination Half-life (t½λz) of AZD7442', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose t½λz of AZD7442 and of the individual mAbs in serum was evaluated.'}, {'measure': 'Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose AUClast of AZD7442 and of the individual mAbs in serum was evaluated.'}, {'measure': 'Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose AUCinf of AZD7442 and of the individual mAbs in serum was evaluated. The bioavailability (F) of AZD7442 Dose 1 administered by IM was calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895 and mAb AZD1061 is also presented.'}, {'measure': 'Systemic Clearance (CL) of AZD7442 IV Infusion', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose CL of AZD7442 and of the individual mAbs in serum was evaluated.'}, {'measure': 'Apparent Total Clearance (CL/F) of AZD7442 IM Injection', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose CL/F of AZD7442 and of the individual mAbs in serum was evaluated.'}, {'measure': 'Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose Vz/F of AZD7442 and of the individual mAbs in serum was evaluated.'}, {'measure': 'Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion', 'timeFrame': 'Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)', 'description': 'The single dose Vss of AZD7442 and of the individual mAbs in serum was evaluated.'}, {'measure': 'Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061', 'timeFrame': 'Day 361 (Post dose)', 'description': 'The ADA response to AZD7442 in serum was evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus', 'Severe acute respiratory syndrome coronavirus 2', 'Pharmacokinetics', 'Safety and tolerability'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '36683419', 'type': 'DERIVED', 'citation': 'Forte-Soto P, Albayaty M, Brooks D, Arends RH, Tillinghast J, Aksyuk AA, Bouquet J, Chen C, Gebre A, Kubiak RJ, Pilla Reddy V, Seegobin S, Streicher K, Templeton A, Esser MT. Safety, Tolerability and Pharmacokinetics of Half-Life Extended Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Monoclonal Antibodies AZD7442 (Tixagevimab-Cilgavimab) in Healthy Adults. J Infect Dis. 2023 May 12;227(10):1153-1163. doi: 10.1093/infdis/jiad014.'}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8850C00001&attachmentIdentifier=fed309b0-1256-498b-9881-da887ad7f778&fileName=__CSR_Full_18_Mar_2022_D8850C00001_(CSR_Synopsis)_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSR synopsis'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8850C00001&attachmentIdentifier=c3a63805-65d0-4dfe-a038-d159f873ea1c&fileName=d8850c00001-csp-amendment-6-final_(redacted)_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSP and SAP'}]}, 'descriptionModule': {'briefSummary': "In this first-in-humans dose escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs). The study is intended to enable future studies of AZD7442's efficacy in preventing and treating COVID-19.", 'detailedDescription': 'This is a Phase I, first time in human, randomised, double-blind, placebo-controlled, and dose escalation study.\n\nThe study will comprise of:\n\n1. A Screening Period of up to 27 days (Day -28 through Day -2);\n2. A Treatment Period during which participants will be resident at the Clinical Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 24 hours after IMP administration, will be discharged on Day 2 after all safety evaluations have been completed, and\n3. A Follow up Period lasting 360 days (through to Day 361) after the IMP dose.\n\nThe study will be conducted at a single study centre in United Kingdom.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent and any locally required authorisation obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.\n* Negative SARS-CoV-2 qRT-PCR and/or serology tests prior to randomisation.\n* Weight ≥ 50 kg and ≤ 110 kg at screening, including a BMI of ≥ 18.0 to ≤ 30.0 kg/m\\^2.\n* Healthy by medical history, physical examination, and baseline safety laboratory studies, according to the judgement of the PI.\n* Electrocardiogram without clinically significant abnormalities at screening.\n* Able to complete the Follow-up Period through Day 361.\n* Females of childbearing potential who are sexually active with a non-sterilised male partner must have used a highly effective method of contraception for at least 28 days prior to dosing with IMP and must agree to continue using such precautions until the Final Follow-up Visit. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component of the IMP.\n* History of allergic disease or reactions likely to be exacerbated by any component of the IMP.\n* Previous hypersensitivity, infusion-related reaction or severe adverse reaction following administration of a mAbs.\n* Acute (time-limited) illness, including fever above 37.5°C (99.5 °F), on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the 27-day Screening Period or may be rescreened once.\n* Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine, or combination over the counter (OTC) product that contains acetaminophen with an antihistamine, or OTC nonsteroidal anti-inflammatory agent at a dose equal to or lower than that recommended on the package). Vitamins and other nutritional supplements that are not newly introduced, ie, have been taken for at least 30 days prior to enrolment, are not exclusionary.\n* Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening.\n* Receipt of immunoglobulin or blood products within 6 months prior to screening.\n* SARS CoV-2 or COVID-19:\n\n * Participants with any confirmed current or previous COVID-19 infection before randomisation.\n * Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnoea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.\n * Any prior receipt of investigational or licensed vaccine indicated for the prevention of SARS CoV-2 or COVID-19 or expected receipt during the period of study follow up.\n* Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study.\n* Previous receipt of a mAb within 6 months, or five antibody half lives (whichever is longer), prior to study start.\n* Immunodeficiency due to illness, including Human immunodeficiency virus (HIV) infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening. HIV testing must be negative at screening.\n* Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening.\n* History of infection with SARS or MERS.\n* Aspartate aminotransferase, ALT, or serum creatinine above the ULN; bilirubin and ALP \\>1.5 × ULN.\n* Haemoglobin or platelet count below the LLN at screening. White blood cell or neutrophil count outside normal references ranges.\n* History of malignancy.\n* Any laboratory value in the screening panel that, in the opinion of the PI, is clinically significant or might confound analysis of study results.\n* Pregnant or nursing female.\n* History of alcohol or drug abuse within the past 2 years that, according to the PI, might affect assessments of safety or ability of participant to comply with all study requirements OR positive urine drug or alcohol screening.\n* Any condition that, in the opinion of the PI, might compromise participant safety or interfere with evaluation of the IMP or interpretation of participant safety or study results.\n* Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.\n* Absence of suitable veins for blood sampling (IM and IV cohorts) and administration of IMP (IV cohorts).'}, 'identificationModule': {'nctId': 'NCT04507256', 'briefTitle': 'AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD7442 in Healthy Adults', 'orgStudyIdInfo': {'id': 'D8850C00001'}, 'secondaryIdInfos': [{'id': '2020-003076-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD7442', 'description': 'Participants will receive AZD7442 doses across five fixed-dose cohorts via intravenous (IV) infusions (three cohorts will be administered sequentially, and one cohort will receive co-administration of AZD8895 + AZD1061, mixed into a single infusion) and direct gluteal intramuscular (IM) injections (administered sequentially).', 'interventionNames': ['Combination Product: AZD7442']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be administered to participants across five fixed-dose cohorts similar to the active treatment.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'AZD7442', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants randomized to AZD7442 will be administered dose 1, each in Cohort 1a (IM) and Cohort 1b (IV). Participants in Cohort 2 and 3 will receive AZD7442 (IV) doses 2 and 3, respectively. Participants in Cohort 4 will receive AZD7442 (IV) dose 4.', 'armGroupLabels': ['AZD7442']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants randomised to placebo will receive the same volume of solution as participants on active treatment.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Pablo Forte Soto, MD, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel EPCU (London)'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}