Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-29 @ 5:45 PM
Study NCT ID:
NCT04817332
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619932', 'term': 'brensocatib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jchalmers@dundee.ac.uk', 'phone': '01382660111', 'title': 'Professor James D Chalmers', 'organization': 'University of Dundee, UK'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '29 days', 'description': 'Adverse events were reported by the participant, site principal investigators or delegated staff responsible for detecting documenting and recording events that met the definition of an adverse event. Participants discharged from hospital before the end of the trial were given a diary to record adverse events up to day 28. Site principal investigators were responsible for assigning seriousness and causality of AEs', 'eventGroups': [{'id': 'EG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 86, 'seriousNumAtRisk': 192, 'deathsNumAffected': 29, 'seriousNumAffected': 40}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 99, 'seriousNumAtRisk': 214, 'deathsNumAffected': 23, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood glucose abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oral mucosal eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tongue blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oral mucosal blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Swollen tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tongue erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tongue discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pruritus', 'notes': 'Pruritis soles of feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Subcutaneous emphysema', 'notes': 'Widespread surgical emphysema in arms and neck, shown in CXR.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Serratia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Steroid diabetes', 'notes': 'Undiagnosed Diabetes (new presentation) - steroid induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'General disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infections', 'notes': 'Including COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Respiratory disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Skin disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of Participant Clinical Status Between Treatment Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Not hospitalized, limitations on activities', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, not requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, on non-invasive ventilation or high flow oxygen devices', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, on invasive mechanical ventilation or ECMO', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.92', 'statisticalMethod': 'Odds ratio Ordinal Logistic Regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for the stratifying factors of age as a fixed effect and site using robust standard errors to account for clustering'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 29 days', 'description': 'To determine the participant clinical status on a 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome:\n\n1. Not hospitalised, no limitations on activities\n2. Not hospitalised, limitation on activities;\n3. Hospitalised, not requiring supplemental oxygen;\n4. Hospitalised, requiring supplemental oxygen;\n5. Hospitalised, on non-invasive ventilation or high flow oxygen devices;\n6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)\n7. Death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Improvement of One Category From Admission Using 7-point Ordinal Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.00', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 29', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome:\n\n1. Not hospitalised, no limitations on activities\n2. Not hospitalised, limitations on activities\n3. Hospitalised, not requiring supplemental oxygen\n4. Hospitalised, requiring supplemental oxygen\n5. Hospitalised, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Days to improvement was derived as\n\n1. days from randomization to date of first follow-up day where there was an improvement in CSTAT\n2. those who died before improvement were censored at date of death.\n3. those who withdrew or were loss to follow-up before improvement, if their day 29 status was unknown, they were censored at the date of loss to follow-up/withdrawal\n4. other participants were censored at day 29 from randomisation in study time if there were no improvement.'}, {'type': 'SECONDARY', 'title': 'Participant Clinical Status on 7-point Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'title': 'Not hospitalised, no limitations on activities', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Not hospitalised, limitations on activities', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalised, not requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalised, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalised, on non-invasive ventilation or high flow oxygen devices', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalised, on invasive mechanical ventilation or ECMO', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome:\n\n1. Not hospitalised, no limitations on activities\n2. Not hospitalised, limitations on activities\n3. Hospitalised, not requiring supplemental oxygen\n4. Hospitalised, requiring supplemental oxygen\n5. Hospitalised, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Mean Change in the 7-point Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'title': 'Baseline to day 29', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to day 15', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to day 11', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to day 8', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to day 5', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to day 3', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to days 3, 5, 8, 11 and 29', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome:\n\n1. Not hospitalised, no limitations on activities\n2. Not hospitalised, limitations on activities\n3. Hospitalised, not requiring supplemental oxygen\n4. Hospitalised, requiring supplemental oxygen\n5. Hospitalised, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)\n7. Death', 'unitOfMeasure': 'Units on WHO scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discharged or to a National Early Warning Score (NEWS) of Equal or Less Than 2 and Maintained for 24 Hours, Whichever Occurs First.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.13', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: National Early Warning Score (NEWS). NEWS is a system that scores 6 physiological parameters (respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, temperature) to give an aggerate score. Minimum score is 1, maximum score is 20.. Higher scores indicate worsening clinical outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Those who died before being discharged or having a NEWS of ≤ 2 were censored at date of death. For those who withdrew or were loss to follow-up before being discharged or having a NEWS of ≤ 2, if their day 29 status was unknown, they were censored at the date of loss to follow-up/withdrawal. Other participants were censored at day 29 or 28 days from randomisation in study time if they were still in hospital and never had a NEWS of ≤ 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of National Early Warning Score (NEWS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'title': '-11', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-9', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '-7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '-5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '-3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '-2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '-1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '0', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to day 15', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: National Early Warning Score. NEWS is a system that scores 6 physiological parameters (respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, temperature) to give an aggerate score. Minimum score is 1, maximum score is 20.. Higher scores indicate worsening clinical outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Oxygen Therapy Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '27'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '27'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.87', 'ciUpperLimit': '0.99', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '1-29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: oxygenation', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT.'}, {'type': 'SECONDARY', 'title': 'Incidence and Duration of New Oxygen Therapy Use During the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.74', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '0-29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: oxygenation', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For the duration of new oxygen use analysis, only participants who were hospitalised but not requiring supplemental oxygen (CSTAT = 3) at baseline were included'}, {'type': 'SECONDARY', 'title': 'Number of Mechanical Ventilator Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '28'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '28'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.04', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '1-29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: Mechanical ventilation', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Incidence and Duration of New Mechanical Ventilation Use During the Trial.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.58', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '1-29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: Mechanical ventilation', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalisation (Days).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.15', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Duration between date of admission and discharge assessed up to 29 days.', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: hospitalisation', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '28-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.88', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to 29', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: mortality. Survival analysis was used to compare 28-day mortality between the treatment arms. Participants who did not die were censored on the last study day. Those who withdrew or were loss to follow-up and their day 29 status was unknown were censored at the date of loss to follow-up/withdrawal. Other participants were censored 28 days from randomisation in study time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-29 days', 'description': 'Evaluation of the safety of the intervention through 29 days of follow-up as compared to the control arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were two post-randomisation exclusions due to ineligibility in the brensocatib group (one patient was admitted to hospital as an inpatient more than 96 h before randomisation and another was receiving a prohibited medication). These 2 excluded patients were included with the ITT population in the safety analysis'}, {'type': 'SECONDARY', 'title': 'Discontinuation or Temporary Suspension of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-29 days', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'SECONDARY', 'title': 'Changes in White Cell Count (x10^9/L) Over Time (Hospitalised Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm', 'unitOfMeasure': '10^9cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Hospitalised participants only'}, {'type': 'SECONDARY', 'title': 'Changes in Haemoglobin (g/L) Over Time (Hospitalised Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '195.4', 'spread': '264', 'groupId': 'OG000'}, {'value': '105.5', 'spread': '21.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm', 'unitOfMeasure': 'g/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Hospitalised participants only'}, {'type': 'SECONDARY', 'title': 'Changes in Platelets (x10^9/L) Over Time (Hospitalised Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '270', 'spread': '94.3', 'groupId': 'OG000'}, {'value': '269', 'spread': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm', 'unitOfMeasure': '10^9cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'SECONDARY', 'title': 'Changes in Creatinine (Umol/L) Over Time (Hospitalised Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '84.9', 'spread': '39', 'groupId': 'OG000'}, {'value': '84.1', 'spread': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Hospitalised patients only'}, {'type': 'SECONDARY', 'title': 'Changes in Total Bilirubin (Umol/L) Over Time (Hospitalised Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'SECONDARY', 'title': 'Changes in Alanine Aminotransferase (U/L) Over Time (Hospitalised Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '43.2', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '92.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'safety'}, {'type': 'SECONDARY', 'title': 'Changes in Aspartate Aminotransferase U/L Over Time (Hospitalised Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '28.8', 'spread': '14.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'SECONDARY', 'title': 'Adverse Events of Special Interest- Hyperkeratosis, Infections and Dental Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'title': 'Hyperkeratosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dental complications', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Secondary infections', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-29 days', 'description': 'Evaluation of the safety of the intervention through 29 days of follow-up as compared to the control arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent of Participants With SARS-CoV-2 Detectable in Nasopharyngeal Sample', 'timeFrame': 'Day 15 and day 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by assessing percent of participants with SARS-CoV-2 detectable in nasopharyngeal sample', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quantitative SARS-CoV-2 Virus in Nasopharyngeal Samples.', 'timeFrame': 'Day 15 and day 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by assessing presence of SARS-CoV-2 virus in nasopharyngeal samples', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neutrophil Elastase and Heparin Binding Protein Measurement in Blood', 'timeFrame': 'Days 1, 8, 15, 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by measuring neutrophil elastase and heparin binding protein measurement in blood', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Neutrophil Elastase Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'spread': '65', 'groupId': 'OG000'}, {'value': '166', 'spread': '97', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-67', 'ciLowerLimit': '-102', 'ciUpperLimit': '-31', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': "Neutrophil elastase activity was measure as follows: whole blood samples were treated with either 10mg/mL zymosan to stimulate neutrophil degranulation or with hanks' balanced salt solution (HBSS) at 37°C for 30 minutes. Following incubation, samples were centrifuged, and blood plasma frozen at -80°C for analysis. Neutrophil elastase activity was subsequently measured by cleavage of the specific fluorogenic substrate MeOSuc-AAPV-AMC. The stimulated elastase activity was calculated by subtracting the plasma elastase activity following incubation with zymosan stimulation from the elastase activity after incubation with buffer alone. Results presents arbitrary fluorescence intensity units (units/mL) as no reference standard is included in the assay. This outcome was included to assess the inhibition of neutrophil serine proteases by DPP1 treatment. Lower values indicate reduced elastase activity.", 'unitOfMeasure': 'Units/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neutrophil Extracellular Trap Release', 'timeFrame': 'Days 1, 15, 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neutrophil Surface Protein Expression Analysis', 'timeFrame': 'Days 1, 15, 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by flow cytometry- CD88, CXCR2, CD66b, CD11b, CD63)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neutrophil Phagocytosis of FITC-labelled Bacteria by Flow Cytometry', 'timeFrame': 'Days 1, 15, 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by flow cytometry', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.003', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.066', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 29', 'description': "To evaluate patient reported outcome measures between the groups using EQ-5D-5L questionnaire. EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has 5 levels. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The total EQ-5D-5L score ranges from -0.594 to 1. A higher total score indicates better outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of Dipeptidyl peptidase-1 (DPP1)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants with data for the primary outcome', 'groupId': 'FG000', 'numSubjects': '187'}, {'comment': 'Participants with data for the primary outcome', 'groupId': 'FG001', 'numSubjects': '211'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This double-blind, randomized, parallel-group, placebo-controlled trial was conducted at 14 secondary care sites in the United Kingdom Between 05th June 2020 and 28 February 2021', 'preAssignmentDetails': 'There were two post-randomisation exclusions due to ineligibility in the Brensocatib arm (one was admitted to hospital as an in-patient more than 96 hours prior to randomisation and another was receiving a prohibited medication). These two patients were included in the safety analysis. Four hundred and four participants (190 Brensocatib and 214 placebo) were included in the intention-to-treat analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days\n\nBrensocatib: Selective, competitive, and reversible inhibitor of DPP1'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days\n\nPlacebo: Matched placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '62.2', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic cardiac disease', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'COPD', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Obesity', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes without complications', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospitalized, not requiring supplemental oxygen', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospitalized, requiring supplemental oxygen', 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospitalized, on non-invasive ventilation or high flow oxygen devices', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention to treat population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-19', 'size': 806835, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-26T13:42', 'hasProtocol': True}, {'date': '2021-04-05', 'size': 332975, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-26T13:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2021-01-25', 'resultsFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-03', 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent of Participants With SARS-CoV-2 Detectable in Nasopharyngeal Sample', 'timeFrame': 'Day 15 and day 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by assessing percent of participants with SARS-CoV-2 detectable in nasopharyngeal sample'}, {'measure': 'Quantitative SARS-CoV-2 Virus in Nasopharyngeal Samples.', 'timeFrame': 'Day 15 and day 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by assessing presence of SARS-CoV-2 virus in nasopharyngeal samples'}, {'measure': 'Neutrophil Elastase and Heparin Binding Protein Measurement in Blood', 'timeFrame': 'Days 1, 8, 15, 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by measuring neutrophil elastase and heparin binding protein measurement in blood'}, {'measure': 'Blood Neutrophil Elastase Activity', 'timeFrame': 'Day 29', 'description': "Neutrophil elastase activity was measure as follows: whole blood samples were treated with either 10mg/mL zymosan to stimulate neutrophil degranulation or with hanks' balanced salt solution (HBSS) at 37°C for 30 minutes. Following incubation, samples were centrifuged, and blood plasma frozen at -80°C for analysis. Neutrophil elastase activity was subsequently measured by cleavage of the specific fluorogenic substrate MeOSuc-AAPV-AMC. The stimulated elastase activity was calculated by subtracting the plasma elastase activity following incubation with zymosan stimulation from the elastase activity after incubation with buffer alone. Results presents arbitrary fluorescence intensity units (units/mL) as no reference standard is included in the assay. This outcome was included to assess the inhibition of neutrophil serine proteases by DPP1 treatment. Lower values indicate reduced elastase activity."}, {'measure': 'Neutrophil Extracellular Trap Release', 'timeFrame': 'Days 1, 15, 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib'}, {'measure': 'Neutrophil Surface Protein Expression Analysis', 'timeFrame': 'Days 1, 15, 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by flow cytometry- CD88, CXCR2, CD66b, CD11b, CD63)'}, {'measure': 'Neutrophil Phagocytosis of FITC-labelled Bacteria by Flow Cytometry', 'timeFrame': 'Days 1, 15, 29', 'description': 'Evaluation of the virologic efficacy of Brensocatib by flow cytometry'}, {'measure': 'Quality of Life Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)', 'timeFrame': 'Day 29', 'description': "To evaluate patient reported outcome measures between the groups using EQ-5D-5L questionnaire. EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has 5 levels. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The total EQ-5D-5L score ranges from -0.594 to 1. A higher total score indicates better outcome."}], 'primaryOutcomes': [{'measure': 'Comparison of Participant Clinical Status Between Treatment Arms', 'timeFrame': 'Up to 29 days', 'description': 'To determine the participant clinical status on a 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome:\n\n1. Not hospitalised, no limitations on activities\n2. Not hospitalised, limitation on activities;\n3. Hospitalised, not requiring supplemental oxygen;\n4. Hospitalised, requiring supplemental oxygen;\n5. Hospitalised, on non-invasive ventilation or high flow oxygen devices;\n6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)\n7. Death.'}], 'secondaryOutcomes': [{'measure': 'Improvement of One Category From Admission Using 7-point Ordinal Scale.', 'timeFrame': 'Day 29', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome:\n\n1. Not hospitalised, no limitations on activities\n2. Not hospitalised, limitations on activities\n3. Hospitalised, not requiring supplemental oxygen\n4. Hospitalised, requiring supplemental oxygen\n5. Hospitalised, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)\n7. Death'}, {'measure': 'Participant Clinical Status on 7-point Ordinal Scale', 'timeFrame': 'Day 15', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome:\n\n1. Not hospitalised, no limitations on activities\n2. Not hospitalised, limitations on activities\n3. Hospitalised, not requiring supplemental oxygen\n4. Hospitalised, requiring supplemental oxygen\n5. Hospitalised, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)\n7. Death'}, {'measure': 'Mean Change in the 7-point Ordinal Scale', 'timeFrame': 'Baseline to days 3, 5, 8, 11 and 29', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome:\n\n1. Not hospitalised, no limitations on activities\n2. Not hospitalised, limitations on activities\n3. Hospitalised, not requiring supplemental oxygen\n4. Hospitalised, requiring supplemental oxygen\n5. Hospitalised, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)\n7. Death'}, {'measure': 'Number of Participants Discharged or to a National Early Warning Score (NEWS) of Equal or Less Than 2 and Maintained for 24 Hours, Whichever Occurs First.', 'timeFrame': 'Up to 29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: National Early Warning Score (NEWS). NEWS is a system that scores 6 physiological parameters (respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, temperature) to give an aggerate score. Minimum score is 1, maximum score is 20.. Higher scores indicate worsening clinical outcomes.'}, {'measure': 'Change From Baseline of National Early Warning Score (NEWS).', 'timeFrame': 'Baseline to day 15', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: National Early Warning Score. NEWS is a system that scores 6 physiological parameters (respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, temperature) to give an aggerate score. Minimum score is 1, maximum score is 20.. Higher scores indicate worsening clinical outcomes.'}, {'measure': 'Number of Oxygen Therapy Free Days', 'timeFrame': '1-29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: oxygenation'}, {'measure': 'Incidence and Duration of New Oxygen Therapy Use During the Trial', 'timeFrame': '0-29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: oxygenation'}, {'measure': 'Number of Mechanical Ventilator Free Days', 'timeFrame': '1-29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: Mechanical ventilation'}, {'measure': 'Incidence and Duration of New Mechanical Ventilation Use During the Trial.', 'timeFrame': '1-29 days', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: Mechanical ventilation'}, {'measure': 'Duration of Hospitalisation (Days).', 'timeFrame': 'Duration between date of admission and discharge assessed up to 29 days.', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: hospitalisation'}, {'measure': '28-day Mortality', 'timeFrame': 'Day 1 to 29', 'description': 'Evaluation of the clinical efficacy of Brensocatib relative to standard care: mortality. Survival analysis was used to compare 28-day mortality between the treatment arms. Participants who did not die were censored on the last study day. Those who withdrew or were loss to follow-up and their day 29 status was unknown were censored at the date of loss to follow-up/withdrawal. Other participants were censored 28 days from randomisation in study time.'}, {'measure': 'Cumulative Incidence of Serious Adverse Events (SAEs)', 'timeFrame': '1-29 days', 'description': 'Evaluation of the safety of the intervention through 29 days of follow-up as compared to the control arm'}, {'measure': 'Discontinuation or Temporary Suspension of Treatment', 'timeFrame': '1-29 days', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm'}, {'measure': 'Changes in White Cell Count (x10^9/L) Over Time (Hospitalised Participants Only)', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm'}, {'measure': 'Changes in Haemoglobin (g/L) Over Time (Hospitalised Participants Only)', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm'}, {'measure': 'Changes in Platelets (x10^9/L) Over Time (Hospitalised Participants Only)', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm'}, {'measure': 'Changes in Creatinine (Umol/L) Over Time (Hospitalised Participants Only)', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm'}, {'measure': 'Changes in Total Bilirubin (Umol/L) Over Time (Hospitalised Participants Only)', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm'}, {'measure': 'Changes in Alanine Aminotransferase (U/L) Over Time (Hospitalised Participants Only)', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm'}, {'measure': 'Changes in Aspartate Aminotransferase U/L Over Time (Hospitalised Participants Only)', 'timeFrame': 'Day 29', 'description': 'Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm'}, {'measure': 'Adverse Events of Special Interest- Hyperkeratosis, Infections and Dental Complications', 'timeFrame': '1-29 days', 'description': 'Evaluation of the safety of the intervention through 29 days of follow-up as compared to the control arm'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 and no therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate the potential of Brensocatib (INS1007) as a novel host directed therapy for the treatment of adult patients hospitalized with COVID-19. The investigators hypothesise that Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen or mechanical ventilation, and shorter length of hospital stay.\n\nHigh rates of patients requiring mechanical ventilation and overwhelming intensive care unit capacity has been the major issue contributing to excess deaths in Italy and Spain during the pandemic and is likely to be a major issue in other countries such as the United Kingdom in the coming weeks. Treatments that could prevent the requirement for mechanical ventilation or shorten the duration of ICU stay by reducing the severity of ARDS are therefore the number 1 target for COVID19 therapy.\n\nThe investigators recently conducted a large phase 2 study of Brensocatib in patients with bronchiectasis designed to test if treatment with Brensocatib could reduce infective exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients. The study met its primary endpoint of time to first exacerbation and key secondary endpoint of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase concentrations in sputum.\n\nParticipants will be randomised to receive Brensocatib or placebo 25mg orally once daily for 28 days.', 'detailedDescription': 'BACKGROUND COVID-19 is a respiratory disease caused by a novel coronavirus severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and causes substantial morbidity and mortality.This clinical trial is designed to evaluate the potential of Brensocatib as a novel host directed therapy for the treatment of adult patients hospitalised with COVID-19. The investigators hypothesise that Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen or mechanical ventilation, and shorter length of hospital stay.\n\nCoronavirus (CoVs) are positive-sense single stranded enveloped Ribonucleic acid (RNA) viruses, many of which are commonly found in humans and cause mild symptoms. Over the past two decades, emerging pathogenic CoVs capable of causing life-threatening disease in humans and animals have been identified, namely severe acute respiratory syndrome (SARS) coronavirus (SARS-CoV) and Middle Eastern respiratory syndrome coronavirus (MERS- CoV).\n\nIn December 2019, the Wuhan Municipal Health Committee (Wuhan, China) identified an outbreak of viral pneumonia cases of unknown cause.5 Coronavirus RNA was quickly identified in some of these patients. This novel coronavirus has been abbreviated as SARS-COV-2 and has 89% nucleotide identity with bat SARS-like-CoVZXC21 and 82% with that of human SARS-CoV. This novel coronavirus has been designated SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Initial infections were travel associated with individuals having contact with Wuhan or other affected areas but the disease has now spread to affect hundreds of thousands of patients worldwide with widespread community transmission across the globe.\n\nOutbreak forecasting and mathematical modelling suggest that these numbers will continue to rise.\n\nGlobal efforts to evaluate novel antivirals and therapeutic strategies to treat COVID-19 have intensified but to date dexamethasone is the only therapy shown to reduce mortality in COVID-19 while repurposed antiviral drugs did not show clinical benefits in the World Health Organisation SOLIDARITY trial.\n\nMortality from COVID-19 has been estimated at between 0.5% and 3.4% of infected patients and occurs most frequently because of the development of ARDS. In contrast to some, particularly bacterial pneumonias, where patients present with acute respiratory failure and sepsis, the dynamics of COVID-19 infection demonstrate a slow deterioration in oxygenation with the development of bilateral infiltrates in a high proportion of patients, consistent with the development of ARDS. Patients subsequently require mechanical ventilation.\n\nTreatments that could prevent the requirement for mechanical ventilation or shorten the duration of intensive care unit stay by reducing the severity of ARDS are therefore the number 1 target for COVID-19 therapy.\n\nNeutrophils in ARDS Neutrophil influx into the extravascular compartments of the lungs is a defining characteristic of ARDS. During ARDS, circulating neutrophils become primed, resulting in reduce deformability and retention within the pulmonary capillary bed. They then migrate across the endothelium through the interstitium and epithelium into the airways themselves. As neutrophils migrate they are activated and release oxidants, proteases and neutrophil extracellular traps. All of these processes are important in killing bacterial pathogens but in ARDS these processes become prolonged and excessive leading to progressive lung damage. Neutrophil elastase and other neutrophil proteases such as proteinase-3 and cathepsin-G cause tissue injury resulting in increased epithelial and endothelial permeability which leads to the influx of protein-rich alveolar oedema.\n\nMortality in ARDS correlates directly with the extent of neutrophilia in the lung. Both human clinical data and murine studies demonstrate a key role for neutrophils in ARDS. Neutrophil depletion in multiple models of ARDS including those induced by lipopolysaccharide, acid, ventilator lung injury, transfusion and other stimuli, reduces the severity of acute lung injury including endothelial-epithelial cell damage and capillary-alveolar permeability.\n\nNeutrophil proteases and particularly neutrophil elastase are believed to be central to the neutrophil induced lung damage. Neutrophil elastase is a serine protease contained within primary neutrophil granules which is released in response to neutrophil activation or neutrophil extracellular trap formation. It is involved in the pathogenesis of multiple inflammatory diseases and therapeutic development of neutrophil elastase inhibitors for use in ARDS has been ongoing for many years. Neutrophil elastase is markedly elevated in human ARDS samples and the inhibition of neutrophil elastase has been demonstrated to reduce epithelial injury in multiple animal models of lung injury across multiple stimuli including lipopolysaccharide (LPS), bleomycin, ventilation, sepsis and many others. Neutrophil elastase is critical to the development of neutrophil extracellular traps, which are highly damaging webs of DNA studded with proteases and other neutrophil derived toxins. Neutrophil extracellular traps (NET) formation and the failure to clear NETs have been strongly implicated in the development and poor outcomes from ARDS. Inhibition of neutrophil elastase reduces the formation of NETs.\n\nA challenge therapeutically has been how to inhibit neutrophil elastase since administration of competitive inhibitors either orally or through the inhaled route may not be sufficient to block elastase activity in the lung.\n\nRATIONALE Neutrophil elastase, proteinase-3 and cathepsin-G are activated during neutrophil maturation in the bone marrow through dipeptidyl peptidase 1 (DPP1; also known as cathepsin C), which removes the N-terminal dipeptide sequence of neutrophil serine proteases allowing active enzymes to be packaged into granules prior to release of neutrophils into the circulation. Brensocatib (INS1007, formerly AZD7986) is an orally delivered selective, competitive, and reversible inhibitor of DPP1. Brensocatib has been shown to inhibit neutrophil serine protease activity in blood in both animal models and healthy volunteers.\n\nThe investigators recently conducted a large phase 2 study of Brensocatib in patients with bronchiectasis designed to test if treatment with Brensocatib could reduce infective exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients. The study met its primary endpoint of time to first exacerbation and key secondary endpoint of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase concentrations in sputum. Due to the need to replace the circulating pool of neutrophils with new neutrophils which are deficient in elastase, Brensocatib does not have its effect immediately, but rather over several days. Elastase concentrations were reduced at the first time point at day 14 in the phase 2 study, with very large reductions observed at the second time point at day 28.\n\nIn a cohort of 191 hospitalised COVID-19 patients with a completed outcome, the median time from illness onset to discharge was 22·0 days (IQR 18·0-25·0) and the median time to death was 18·5 days (15·0-22·0). Thirty-two patients (17%) required invasive mechanical ventilation and the median time from onset to mechanical ventilation was 14.5 days. The investigators hypothesise that the mechanism of action of Brensocatib to reduce protease activity will be more rapid in COVID-19 patients compared to bronchiectasis due to a more rapid turnover of neutrophils in acute illness. The objective is to test whether by reducing neutrophil protease activity in neutrophils the investigatorscan prevent or reverse the development of ARDS and thereby improve outcomes in individuals with COVID-19 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n6.1. Inclusion criteria\n\n• Male or female\n\n* ≥16 years of age\n* SARS-CoV-2 infection (clinically suspected+ or laboratory confirmed\\*).\n* Admitted to hospital as in-patient less than 96 hours prior to randomisation\\^\n* Illness of any duration, and at least one of the following:\n\n * Radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (CT) scan) OR\n * Evidence of rales/crackles on physical examination OR\n * Peripheral capillary oxygen saturation (SpO2) ≤94% on room air prior to randomization OR\n * Requiring supplemental oxygen. OR\n * Lymphocyte count \\<1 x 109 cells per litre (L)\n* Participant (or legally authorized representative) provides written informed consent\n* Able to take oral medication\n* Participant (or legally authorised representative) understands and agrees to comply with planned trial procedures.\n\n * Laboratory-confirmed: SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen \\< 96 hours prior to randomization.\n\n * Clinically suspected: in general, SARS-CoV-2 infection should be suspected when a patient presents with (i) typical symptoms (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and (ii) compatible chest X-ray findings (consolidation or ground-glass shadowing); and (iii) alternative causes have been considered unlikely or excluded (e.g. heart failure, influenza). However, the diagnosis remains a clinical one based on the opinion of the managing doctor\n\n * Where a patient has been admitted to hospital for a non COVID-19 reason and develops COVID-19 symptoms whilst an in-patient, randomisation may occur up to 96 hours from onset of symptoms.\n\nExclusion Criteria:\n\n* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\> 5 times the upper limit of normal, result within 72 hours of randomization (the result closest to randomization should be used if several results are available).\n* History of severe liver disease\n* Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated Glomerular Filtration Rate \\< 30), result within 72 hours of randomization (the result closest to randomization should be used if several results are available)\n* Absolute neutrophil count less than 1.0 x 109 cells per L within 72 hours of randomization (the result closest to randomization should be used if several results are available)\n* Current treatments with potent Cyp3A4 inducers/inhibitors (e.g Itraconazole, Ketoconazole, diltiazem, verapamil, phenytoin or rifampicin)\n* HIV treatments - current treatment with protease/integrase inhibitors or non-nucleoside reverse transcriptase inhibitors\\*\n* Pregnant or breast feeding.\n* Anticipated transfer to another hospital which is not a trial site within 24 hours.\n* Allergy to Brensocatib\n* Use of any investigational drug within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer. Co-enrolment with COVID-19 trials is allowed as per co-enrolment agreements and/or individual decision by the Chief Investigator.\n\nWomen of child-bearing potential must be willing to have pregnancy testing prior to trial entry.\n\n\\*The Liverpool HIV checker (https://www.hiv-druginteractions.org/checker) should be used to check for any HIV drug interactions. Simvastatin could be used as a surrogate for Brensocatib as it metabolised similarly by CYP 3A4 pathway.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04817332', 'acronym': 'STOP-COVID19', 'briefTitle': 'STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Dundee'}, 'officialTitle': 'A Randomised Double-blind Placebo-controlled Trial of Brensocatib (INS1007) in Patients With Severe COVID-19', 'orgStudyIdInfo': {'id': '01.01.20'}, 'secondaryIdInfos': [{'id': '2020-001643-13', 'type': 'EUDRACT_NUMBER'}, {'id': '281986', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brensocatib', 'description': 'Brensocatib oral tablet, 25mg once per day for 28 days', 'interventionNames': ['Drug: Brensocatib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral tablet, 25mg once per day for 28 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Brensocatib', 'type': 'DRUG', 'otherNames': ['INS1007'], 'description': 'Selective, competitive, and reversible inhibitor of DPP1', 'armGroupLabels': ['Brensocatib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'NHS Grampian', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Royal United Hospitals Bath NHS Foundation Trust', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Cardiff & Vale University Health Board', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'NHS Tayside', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Dunfermline', 'country': 'United Kingdom', 'facility': 'NHS Fife', 'geoPoint': {'lat': 56.07156, 'lon': -3.45887}}, {'city': 'Frimley', 'country': 'United Kingdom', 'facility': 'Frimley Health NHS Foundation Trust', 'geoPoint': {'lat': 51.31667, 'lon': -0.74544}}, {'city': 'Harlow', 'country': 'United Kingdom', 'facility': 'Princess Alexandra Hospital NHS Trust', 'geoPoint': {'lat': 51.77655, 'lon': 0.11158}}, {'city': 'Inverness', 'country': 'United Kingdom', 'facility': 'NHS Highland', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'city': 'Larbert', 'country': 'United Kingdom', 'facility': 'NHS Forth Valley', 'geoPoint': {'lat': 56.02246, 'lon': -3.82872}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'University Hospitals North Midlands NHS Trust', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'city': 'Wishaw', 'country': 'United Kingdom', 'facility': 'NHS Lanarkshire', 'geoPoint': {'lat': 55.76667, 'lon': -3.91667}}], 'overallOfficials': [{'name': 'James Chalmers', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dundee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dundee', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Tayside', 'class': 'OTHER_GOV'}, {'name': 'Insmed Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Respiratory Research', 'investigatorFullName': 'James Chalmers', 'investigatorAffiliation': 'University of Dundee'}}}}