Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:47 PM
Study NCT ID:
NCT04535167
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2020-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'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': 'C000714028', 'term': 'lufotrelvir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From pre-dose on Day 1 up to 41 days', 'description': 'The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Tinea cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Stoma site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Haematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'All-causality TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'All-causality SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'All-causality severe AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related severe AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to 37 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'All-causality TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'All-causality SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'All-causality severe AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related severe AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to 41 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a treatment-emergent adverse event (TEAE) if the event started during the effective duration of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'Discontinued from study due to adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Discontinuation from study drug due to AE and continued study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dose reduced or temporary discontinuation due to adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 37 days', 'description': 'An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Discontinued from study due to adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Discontinuation from study drug due to AE and continued study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dose reduced or temporary discontinuation due to adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to 41 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'Lymphocytes (10^3/mm3) < 0.8*LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Basophils (10^3/mm3) > 1.2*ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase (U/L) > 3.0*ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Alanine Aminotransferase (U/L) > 3.0*ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Calcium (mg/dL) < 0.9*LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bicarbonate (mEq/L) < 0.9*LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Glucose (mg/dL) > 1.5*ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Glucose - FASTING (mg/dL) >1.5*ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'URINE Glucose ≥ 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'URINE Hemoglobin ≥ 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Urobilinogen ≥ 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'URINE Erythrocytes (/HPF) ≥ 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 6 days', 'description': 'Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes, basophiles; Clinical Chemistry - aspartate aminotransferase, alanine aminotransferase, calcium, bicarbonate, glucose, glucose -FASTING; Urinalysis - urine glucose, urine hemoglobin, urobilinogen and urine erythrocytes (per high power field).\n\nBaseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific parameters.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Hemoglobin (g/dL)<0.8*LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit (%)<0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Erythrocytes (10^6/mm3)<0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ery. mean corpuscular volume (um^3)<0.9*LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ery. mean corpuscular hemoglobin (pg/cell)<0.9*LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes (10^3/mm3)<0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase (U/L)>3.0*ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Protein (g/dL)<0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Albumin (g/dL) <0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Urea nitrogen (mg/dL)>1.3x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine (mg/dL)>1.3x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'HDL cholesterol (mg/dL)<0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides (mg/dL)>1.3x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Calcium (mg/dL)<0.9x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Phosphate (mg/dL)<0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate (mEq/L)<0.9x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Glucose (mg/dL)>1.5x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'URINE glucose≥1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ketones≥1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Urine hemoglobin ≥ 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Urobilinogen≥1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Nitrite≥1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocyte esterase ≥ 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Urine erythrocytes (/HPF)≥20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Urine leukocytes (Scalar)≥20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 41 days', 'description': 'Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular, hemoglobin; Clinical Chemistry - alanine aminotransferase, protein, albumin, urea nitrogen, creatinine, HDL cholesterol, triglycerides, calcium, phosphate, bicarbonate, glucose; Urinalysis - urine glucose, ketones, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase, urine erythrocytes (per high power field), urine leukocytes (Scalar).\n\nBaseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific parameters.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'Systolic blood pressure: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '116.0', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '134.5', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '108.0', 'spread': '14.14', 'groupId': 'OG002'}, {'value': '127.5', 'spread': '30.41', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Day 1- 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '18.38', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '12.02', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '12.73', 'groupId': 'OG002'}, {'value': '9.5', 'spread': '17.68', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '22.63', 'groupId': 'OG000'}, {'value': '-20.0', 'spread': '11.31', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '20.51', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '14.85', 'groupId': 'OG000'}, {'value': '-20.5', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '7.07', 'groupId': 'OG002'}, {'value': '16.5', 'spread': '24.75', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '18.38', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '26.16', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '5.66', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '-17.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '8.49', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '5.66', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '-16.5', 'spread': '21.92', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '9.90', 'groupId': 'OG002'}, {'value': '13.5', 'spread': '3.54', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-20.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '-14.5', 'spread': '27.58', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.0', 'spread': '9.90', 'groupId': 'OG000'}, {'value': '59.0', 'spread': '21.21', 'groupId': 'OG001'}, {'value': '68.5', 'spread': '13.44', 'groupId': 'OG002'}, {'value': '76.5', 'spread': '9.19', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '14.14', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '8.49', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '9.90', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '7.78', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '4.24', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '11.31', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '6.36', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '17.68', 'groupId': 'OG001'}, {'value': '-8.0', 'spread': '7.07', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '7.78', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '9.90', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '16.97', 'groupId': 'OG001'}, {'value': '-8.5', 'spread': '2.12', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '23.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-7.5', 'spread': '6.36', 'groupId': 'OG002'}, {'value': '-4.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '8.5', 'spread': '2.12', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG000'}, {'value': '17.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG001'}, {'value': '-11.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '12.73', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1), Day 1-30 minutes, 2 hours, 6 hour, and 12 hours; 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).', 'description': 'Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Systolic blood pressure: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '105.3', 'spread': '18.08', 'groupId': 'OG000'}, {'value': '127.6', 'spread': '13.64', 'groupId': 'OG001'}, {'value': '116.5', 'spread': '14.29', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '10.34', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '14.20', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '8.42', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '14.15', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '16.92', 'groupId': 'OG001'}, {'value': '10.8', 'spread': '24.70', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '12.54', 'groupId': 'OG000'}, {'value': '-13.1', 'spread': '13.59', 'groupId': 'OG001'}, {'value': '-18.0', 'spread': '6.00', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '10.28', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '14.14', 'groupId': 'OG001'}, {'value': '-12.3', 'spread': '6.66', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '14.85', 'groupId': 'OG000'}, {'value': '-11.6', 'spread': '12.71', 'groupId': 'OG001'}, {'value': '-11.0', 'spread': '6.08', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '10.83', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '17.29', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.5', 'spread': '17.62', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '48.08', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '14.07', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '17.01', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '6.66', 'groupId': 'OG001'}, {'value': '15.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.8', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '78.7', 'spread': '7.87', 'groupId': 'OG001'}, {'value': '72.0', 'spread': '12.52', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '10.52', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '7.48', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '9.83', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '13.15', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '9.54', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '8.57', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '9.32', 'groupId': 'OG001'}, {'value': '-11.7', 'spread': '4.93', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '10.05', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '11.62', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '11.27', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '8.96', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '17.00', 'groupId': 'OG001'}, {'value': '-13.0', 'spread': '2.00', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '13.86', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '12.04', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '13.48', 'groupId': 'OG000'}, {'value': '-34.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '1.41', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '13.64', 'groupId': 'OG000'}, {'value': '-14.5', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '21.63', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '12.66', 'groupId': 'OG001'}, {'value': '12.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1), Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET) .', 'description': 'Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'Pulse rate: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '4.95', 'groupId': 'OG001'}, {'value': '66.0', 'spread': '16.97', 'groupId': 'OG002'}, {'value': '75.5', 'spread': '6.36', 'groupId': 'OG003'}]}]}, {'title': 'Pulse rate: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '10.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Pulse rate: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '16.0', 'spread': '24.04', 'groupId': 'OG003'}]}]}, {'title': 'Pulse rate: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-7.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-11.0', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '7.07', 'groupId': 'OG003'}]}]}, {'title': 'Pulse rate: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '17.68', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '10.61', 'groupId': 'OG002'}, {'value': '-17.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}, {'title': 'Pulse rate: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '15.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}, {'title': 'Pulse rate: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '9.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1), 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day 1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).', 'description': 'Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Pulse rate: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '10.59', 'groupId': 'OG000'}, {'value': '80.9', 'spread': '13.15', 'groupId': 'OG001'}, {'value': '90.3', 'spread': '30.38', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '16.82', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '10.64', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '4.12', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '11.52', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '20.90', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '8.60', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '17.47', 'groupId': 'OG000'}, {'value': '-10.6', 'spread': '10.39', 'groupId': 'OG001'}, {'value': '-18.3', 'spread': '24.79', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '11.11', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '12.61', 'groupId': 'OG001'}, {'value': '-12.0', 'spread': '22.07', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '20.65', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '16.34', 'groupId': 'OG001'}, {'value': '-19.7', 'spread': '45.39', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '9.93', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '12.58', 'groupId': 'OG001'}, {'value': '-11.3', 'spread': '32.46', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '-38.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG001'}, {'value': '-25.5', 'spread': '24.75', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '10.24', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '29.70', 'groupId': 'OG001'}, {'value': '-7.7', 'spread': '28.36', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '12.73', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '24.95', 'groupId': 'OG001'}, {'value': '12.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).', 'description': 'Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'Temperature: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.6', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '37.1', 'spread': '0.99', 'groupId': 'OG003'}]}]}, {'title': 'Temperature: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': 'Temperature: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.57', 'groupId': 'OG003'}]}]}, {'title': 'Temperature: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Temperature: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.42', 'groupId': 'OG003'}]}]}, {'title': 'Temperature: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.64', 'groupId': 'OG003'}]}]}, {'title': 'Temperature: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.85', 'groupId': 'OG003'}]}]}, {'title': 'Temperature: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.3', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).', 'description': 'Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.', 'unitOfMeasure': 'Degree Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Temperature: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.7', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '36.3', 'spread': '0.73', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.29', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.40', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.55', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.45', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.57', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.08', 'groupId': 'OG002'}]}]}, {'title': 'Temperature: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).', 'description': 'Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.', 'unitOfMeasure': 'Degree Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'Respiratory rate: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.0', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '23.0', 'spread': '7.07', 'groupId': 'OG002'}, {'value': '20.0', 'spread': '2.83', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '4.24', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '4.24', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '7.78', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '10.61', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory rate: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '3.54', 'groupId': 'OG002'}, {'value': '7.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '7.78', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '4.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-8.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '5.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).', 'description': 'Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Respiratory rate: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.5', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '5.59', 'groupId': 'OG001'}, {'value': '21.0', 'spread': '4.69', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '7.45', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '5.07', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '4.26', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '4.97', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '5.69', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '5.00', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '2.04', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '2.08', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '5.62', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '3.51', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '4.55', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '4.88', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '10.12', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory rate: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '4.73', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).', 'description': 'Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'Baseline: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '90.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '98.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '94.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '95.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline: End of Treatment: Oxygen Received Throughout:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: End of Treatment: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline: Follow Up 1: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 1: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline: Follow Up 2: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline: Follow Up 2: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline: Follow Up 2: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); Day1-24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)', 'description': 'Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement.\n\nSpO2 = arterial oxygen saturation.', 'unitOfMeasure': 'percentage of SpO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who take at least 1 dose of study intervention for the Part 1. Participants will be analyzed according to the product they actually received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Baseline: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '96.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '60.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '96.0', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '97.3', 'spread': '0.58', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Day 2: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '34.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Day 2: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '2.08', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Day 2: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Day 3: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '31.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Day 3: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Day 3: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Day 4: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '29.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Day 4: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Day 4: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Day 5: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '3.79', 'groupId': 'OG001'}, {'value': '25.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Day 5: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '3.54', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Day 5: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: End of Treatment: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '34.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: End of Treatment: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Early Termination: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Early Termination: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Early Termination: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 1: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '36.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 1: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Follow Up 2: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '31.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 2: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 2: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 3: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '31.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 3: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 3: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 4: Oxygen Received Throughout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline: Follow Up 4: Oxygen Received at Some Point During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline: Follow Up 4: Oxygen Never Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination (ET).', 'description': 'Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement.\n\nSpO2 = arterial oxygen saturation.', 'unitOfMeasure': 'percentage of SpO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who take at least 1 dose of study intervention for the Part 2. Participants will be analyzed according to the product they actually received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'ECG mean heart rate: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.5', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '71.5', 'spread': '4.95', 'groupId': 'OG001'}, {'value': '66.0', 'spread': '15.56', 'groupId': 'OG002'}, {'value': '71.0', 'spread': '7.07', 'groupId': 'OG003'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '-13.5', 'spread': '9.19', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '13.44', 'groupId': 'OG003'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '5.66', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '3.54', 'groupId': 'OG002'}, {'value': '8.5', 'spread': '10.61', 'groupId': 'OG003'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '7.07', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '10.61', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '2.83', 'groupId': 'OG003'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '8.0', 'spread': '5.66', 'groupId': 'OG003'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '-8.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1. Participants were analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'ECG mean heart rate: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.2', 'spread': '9.02', 'groupId': 'OG000'}, {'value': '80.1', 'spread': '11.29', 'groupId': 'OG001'}, {'value': '85.0', 'spread': '41.16', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '8.52', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '18.90', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '2.08', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '15.49', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '15.01', 'groupId': 'OG001'}, {'value': '-7.5', 'spread': '18.91', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '13.28', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '8.04', 'groupId': 'OG001'}, {'value': '-13.7', 'spread': '27.61', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '16.65', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '13.46', 'groupId': 'OG001'}, {'value': '-15.0', 'spread': '42.79', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '17.73', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '8.63', 'groupId': 'OG001'}, {'value': '21.0', 'spread': '10.44', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '12.68', 'groupId': 'OG000'}, {'value': '-26.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '12.07', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '16.26', 'groupId': 'OG001'}, {'value': '6.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'ECG mean heart rate: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '21.38', 'groupId': 'OG001'}, {'value': '21.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2. Participants were analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'OG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'PR interval: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '153.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '165.0', 'spread': '29.70', 'groupId': 'OG001'}, {'value': '171.0', 'spread': '16.97', 'groupId': 'OG002'}, {'value': '183.5', 'spread': '10.61', 'groupId': 'OG003'}]}]}, {'title': 'PR interval: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '7.78', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '-14.5', 'spread': '4.95', 'groupId': 'OG003'}]}]}, {'title': 'PR interval: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '19.80', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '3.54', 'groupId': 'OG002'}, {'value': '-19.5', 'spread': '4.95', 'groupId': 'OG003'}]}]}, {'title': 'PR interval: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '10.61', 'groupId': 'OG001'}, {'value': '-7.5', 'spread': '6.36', 'groupId': 'OG002'}, {'value': '-7.0', 'spread': '5.66', 'groupId': 'OG003'}]}]}, {'title': 'PR interval: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '12.73', 'groupId': 'OG002'}, {'value': '-16.5', 'spread': '6.36', 'groupId': 'OG003'}]}]}, {'title': 'PR interval: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-7.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '-11.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}, {'title': 'QRS interval: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.5', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '99.0', 'spread': '4.24', 'groupId': 'OG001'}, {'value': '95.0', 'spread': '8.49', 'groupId': 'OG002'}, {'value': '103.0', 'spread': '4.24', 'groupId': 'OG003'}]}]}, {'title': 'QRS interval: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.41', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '12.73', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': 'QRS interval: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '5.66', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '3.54', 'groupId': 'OG003'}]}]}, {'title': 'QRS interval: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '6.36', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '4.24', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'QRS interval: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '2.83', 'groupId': 'OG003'}]}]}, {'title': 'QRS interval: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}, {'title': 'QT interval: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '348.5', 'spread': '30.41', 'groupId': 'OG000'}, {'value': '401.0', 'spread': '48.08', 'groupId': 'OG001'}, {'value': '397.5', 'spread': '30.41', 'groupId': 'OG002'}, {'value': '389.0', 'spread': '22.63', 'groupId': 'OG003'}]}]}, {'title': 'QT interval: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '21.92', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '12.73', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '14.14', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '10.61', 'groupId': 'OG000'}, {'value': '-16.5', 'spread': '24.75', 'groupId': 'OG001'}, {'value': '19.5', 'spread': '38.89', 'groupId': 'OG002'}, {'value': '-13.5', 'spread': '28.99', 'groupId': 'OG003'}]}]}, {'title': 'QT interval: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.5', 'spread': '30.41', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '30.0', 'spread': '19.80', 'groupId': 'OG002'}, {'value': '-20.0', 'spread': '28.28', 'groupId': 'OG003'}]}]}, {'title': 'QT interval: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.0', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '36.06', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '37.48', 'groupId': 'OG002'}, {'value': '15.0', 'spread': '11.31', 'groupId': 'OG003'}]}]}, {'title': 'QT interval: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.5', 'spread': '26.16', 'groupId': 'OG000'}, {'value': '2.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-12.0', 'spread': '15.56', 'groupId': 'OG002'}, {'value': '-8.5', 'spread': '2.12', 'groupId': 'OG003'}]}]}, {'title': 'QT interval: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-23.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '38.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}, {'title': 'QTcF: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '395.0', 'spread': '28.28', 'groupId': 'OG000'}, {'value': '423.0', 'spread': '41.01', 'groupId': 'OG001'}, {'value': '408.0', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '411.5', 'spread': '10.61', 'groupId': 'OG003'}]}]}, {'title': 'QTcF: Change from Baseline: Day 1 - 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '19.80', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '14.14', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '9.19', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Day 1 - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '23.33', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '21.92', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '7.07', 'groupId': 'OG003'}]}]}, {'title': 'QTcF: Change from Baseline: Day 1 - 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '7.07', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '17.68', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': '9.90', 'groupId': 'OG003'}]}]}, {'title': 'QTcF: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.5', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '14.14', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '16.26', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '6.36', 'groupId': 'OG003'}]}]}, {'title': 'QTcF: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-19.0', 'spread': '15.56', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '9.90', 'groupId': 'OG003'}]}]}, {'title': 'QTcF: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-21.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}, {'value': '24.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.', 'unitOfMeasure': 'Millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1. Participants were analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'PRIMARY', 'title': 'Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG002', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'PR interval: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '145.7', 'spread': '12.86', 'groupId': 'OG000'}, {'value': '139.7', 'spread': '19.14', 'groupId': 'OG001'}, {'value': '156.0', 'spread': '28.31', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '14.76', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '15.17', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '4.51', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '17.88', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '9.91', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '11.36', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '19.81', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '13.50', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '14.14', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '15.46', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '15.82', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '7.64', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '18.63', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '17.86', 'groupId': 'OG001'}, {'value': '-8.0', 'spread': '18.36', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '28.85', 'groupId': 'OG000'}, {'value': '-30.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '24.45', 'groupId': 'OG000'}, {'value': '-21.0', 'spread': '31.11', 'groupId': 'OG001'}, {'value': '-18.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'PR interval: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '19.31', 'groupId': 'OG001'}, {'value': '-23.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '93.6', 'spread': '10.63', 'groupId': 'OG001'}, {'value': '90.5', 'spread': '4.43', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '5.09', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '7.09', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '5.32', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '3.30', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '3.92', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '5.29', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '5.56', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '3.51', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '6.43', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '6.35', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '16.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '8.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.86', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '5.66', 'groupId': 'OG001'}, {'value': '15.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QRS interval: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '3.61', 'groupId': 'OG001'}, {'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '385.5', 'spread': '24.74', 'groupId': 'OG000'}, {'value': '366.1', 'spread': '22.17', 'groupId': 'OG001'}, {'value': '373.8', 'spread': '59.57', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.3', 'spread': '35.59', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '48.16', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '9.07', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.5', 'spread': '59.06', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '43.01', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '37.34', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '31.04', 'groupId': 'OG000'}, {'value': '29.0', 'spread': '21.57', 'groupId': 'OG001'}, {'value': '28.0', 'spread': '61.54', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '46.10', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '31.07', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '60.61', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-17.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.2', 'spread': '39.09', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '16.82', 'groupId': 'OG001'}, {'value': '-49.7', 'spread': '32.59', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-19.3', 'spread': '27.00', 'groupId': 'OG000'}, {'value': '63.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-22.0', 'spread': '22.17', 'groupId': 'OG000'}, {'value': '24.5', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '-21.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QT interval: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '39.36', 'groupId': 'OG001'}, {'value': '-36.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '404.7', 'spread': '18.13', 'groupId': 'OG000'}, {'value': '401.3', 'spread': '10.44', 'groupId': 'OG001'}, {'value': '405.3', 'spread': '18.84', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '20.96', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '19.75', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '7.94', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '27.66', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '21.80', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '24.19', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '11.82', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '20.74', 'groupId': 'OG001'}, {'value': '19.7', 'spread': '39.37', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '16.50', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '17.93', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '15.50', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Follow Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '9.09', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '18.43', 'groupId': 'OG001'}, {'value': '-15.7', 'spread': '23.01', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Follow Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '9.00', 'groupId': 'OG000'}, {'value': '18.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG001'}, {'value': '9.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Follow Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '-7.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}, {'title': 'QTcF: Change from Baseline: Follow Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '19.43', 'groupId': 'OG001'}, {'value': '7.0', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.', 'unitOfMeasure': 'Millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2. Participants were analyzed according to the product they received.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.'}, {'type': 'SECONDARY', 'title': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at 24 Hours (End of Infusion) - Part 1: SAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}], 'classes': [{'title': 'C24 of PF-07304814', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and CV is not applicable with n=1.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and CV is not applicable due to n\\<3.', 'groupId': 'OG001'}]}]}, {'title': 'C24 of PF-00835231', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and CV is not applicable with n=1.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and CV is not applicable due to n\\<3.', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 6 hours post-dose on Day 1; 24 hours; 48 hours; and/or early termination.', 'description': 'C24 was defined as concentration at 24 hours. 24-hour PK draw was approximately 4 hours post end of infusion which corresponded to 28 hours.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 1: SAD.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.'}, {'type': 'SECONDARY', 'title': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameter: Concentration at 120 Hours (End of Infusion) - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'C120 of PF-07304814', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '197.2', 'spread': '72', 'groupId': 'OG000'}, {'value': '91.64', 'spread': '51', 'groupId': 'OG001'}]}]}, {'title': 'C120 of PF-00835231', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1338', 'spread': '84', 'groupId': 'OG000'}, {'value': '800.8', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.', 'description': 'C120 was defined as concentration at 120 hours. Blood sample collection at approximately at 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.'}, {'type': 'SECONDARY', 'title': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Cmax of PF-07304814', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '345.3', 'spread': '70', 'groupId': 'OG000'}, {'value': '272.6', 'spread': '281', 'groupId': 'OG001'}]}]}, {'title': 'Cmax of PF-00835231', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2382', 'spread': '36', 'groupId': 'OG000'}, {'value': '1265', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.', 'description': 'Cmax was defined as maximum observed concentration. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.'}, {'type': 'SECONDARY', 'title': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 't½ of PF-07304814', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 't½ of PF-00835231', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.79', 'spread': 'NA', 'comment': 'Standard deviation was not applicable because only 1 participant was analyzed.', 'groupId': 'OG000'}, {'value': '2.317', 'spread': '0.96547', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.', 'description': 't½ was defined as terminal half-life. Blood sample collection at approximately within 30 minutes before end of infusion (\\~120 hours), and at 2 and 6 hours post the end of the infusion, which correspond to approximately 122h and 126h post the start of infusion.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.'}, {'type': 'SECONDARY', 'title': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'OG001', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'classes': [{'title': 'Css of PF-07304814', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '229.2', 'spread': '61', 'groupId': 'OG000'}, {'value': '102.2', 'spread': '35', 'groupId': 'OG001'}]}]}, {'title': 'Css of PF-00835231', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1720', 'spread': '44', 'groupId': 'OG000'}, {'value': '970.2', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.', 'description': 'Css was defined as concentration at steady state. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD.\n\nNumber of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'FG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'FG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'FG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'FG004', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'FG005', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'FG006', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}], 'periods': [{'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}, {'title': 'Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'comment': 'Participant may or may not continued in follow-up period after discontinuing from the treatment period.', 'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 26 hospitalized participants with COVID-19 were enrolled in this study. 25 participants were randomized to receive single ascending (24-hour, part 1) or multiple ascending (120-hour, part 2) intravenous infusions of PF-07304814 or placebo. One participant was not treated and discontinued from study due to being incorrectly randomized. All reported data are on 25 participants who were randomized and received at least 1 dose of PF-07304814 or placebo (referred to as "enrolled" herein).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: PF-07304814 500 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.'}, {'id': 'BG001', 'title': 'Part 1: PF-07304814 250 mg 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.'}, {'id': 'BG002', 'title': 'Part 1: 500 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'BG003', 'title': 'Part 1: 250 mg Placebo 24-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.'}, {'id': 'BG004', 'title': 'Part 2: PF-07304814 500 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'BG005', 'title': 'Part 2: PF-07304814 250 mg 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'BG006', 'title': 'Part 2: Placebo 120-hours Continuous Infusion', 'description': 'Participants were enrolled in this arm and received placebo as 5-day (\\~120 hours) continuous intravenous infusion.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-15', 'size': 7560891, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-06T15:37', 'hasProtocol': True}, {'date': '2021-06-29', 'size': 3567789, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-06T15:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Part 1 will have 2 planned cohorts. Each escalating cohort will be initiated for enrollment after assessment of safety, tolerability and PK data from previous cohorts by an independent IRC and is deemed acceptable.\n\nPart 2 will have 2 planned cohort and each escalating cohort will be initiated after all safety, tolerability and PK data from previous cohort is evaluated and is deemed acceptable by a competent regulatory authority.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2020-08-21', 'resultsFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-28', 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD', 'timeFrame': 'Day 1 to 37 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.'}, {'measure': 'Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD', 'timeFrame': 'Day 1 to 41 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a treatment-emergent adverse event (TEAE) if the event started during the effective duration of treatment.'}, {'measure': 'Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD', 'timeFrame': 'Day 1 up to 37 days', 'description': 'An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment.'}, {'measure': 'Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD', 'timeFrame': 'Day 1 to 41 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.'}, {'measure': 'Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD', 'timeFrame': 'Day 1 up to 6 days', 'description': 'Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes, basophiles; Clinical Chemistry - aspartate aminotransferase, alanine aminotransferase, calcium, bicarbonate, glucose, glucose -FASTING; Urinalysis - urine glucose, urine hemoglobin, urobilinogen and urine erythrocytes (per high power field).\n\nBaseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal.'}, {'measure': 'Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD', 'timeFrame': 'Day 1 up to 41 days', 'description': 'Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular, hemoglobin; Clinical Chemistry - alanine aminotransferase, protein, albumin, urea nitrogen, creatinine, HDL cholesterol, triglycerides, calcium, phosphate, bicarbonate, glucose; Urinalysis - urine glucose, ketones, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase, urine erythrocytes (per high power field), urine leukocytes (Scalar).\n\nBaseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal'}, {'measure': 'Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'timeFrame': 'Baseline (pre-dose Day 1), Day 1-30 minutes, 2 hours, 6 hour, and 12 hours; 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).', 'description': 'Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.'}, {'measure': 'Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD', 'timeFrame': 'Baseline (pre-dose Day 1), Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET) .', 'description': 'Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.'}, {'measure': 'Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'timeFrame': 'Baseline (pre-dose Day 1), 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day 1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).', 'description': 'Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.'}, {'measure': 'Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).', 'description': 'Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.'}, {'measure': 'Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'timeFrame': 'Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).', 'description': 'Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.'}, {'measure': 'Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).', 'description': 'Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.'}, {'measure': 'Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'timeFrame': 'Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).', 'description': 'Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.'}, {'measure': 'Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).', 'description': 'Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.'}, {'measure': 'Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'timeFrame': 'Baseline (pre-dose Day 1); Day1-24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)', 'description': 'Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement.\n\nSpO2 = arterial oxygen saturation.'}, {'measure': 'Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination (ET).', 'description': 'Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement.\n\nSpO2 = arterial oxygen saturation.'}, {'measure': 'Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'timeFrame': 'Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.'}, {'measure': 'Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.'}, {'measure': 'Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD', 'timeFrame': 'Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.'}, {'measure': 'Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD', 'timeFrame': 'Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.'}], 'secondaryOutcomes': [{'measure': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at 24 Hours (End of Infusion) - Part 1: SAD', 'timeFrame': 'Pre-dose and 6 hours post-dose on Day 1; 24 hours; 48 hours; and/or early termination.', 'description': 'C24 was defined as concentration at 24 hours. 24-hour PK draw was approximately 4 hours post end of infusion which corresponded to 28 hours.'}, {'measure': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameter: Concentration at 120 Hours (End of Infusion) - Part 2: MAD', 'timeFrame': 'Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.', 'description': 'C120 was defined as concentration at 120 hours. Blood sample collection at approximately at 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.'}, {'measure': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD', 'timeFrame': 'Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.', 'description': 'Cmax was defined as maximum observed concentration. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.'}, {'measure': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD', 'timeFrame': 'Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.', 'description': 't½ was defined as terminal half-life. Blood sample collection at approximately within 30 minutes before end of infusion (\\~120 hours), and at 2 and 6 hours post the end of the infusion, which correspond to approximately 122h and 126h post the start of infusion.'}, {'measure': 'PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD', 'timeFrame': 'Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.', 'description': 'Css was defined as concentration at steady state. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-COV-2'], 'conditions': ['Viral Disease']}, 'referencesModule': {'references': [{'pmid': '37559753', 'type': 'DERIVED', 'citation': 'Robinson P, Toussi SS, Aggarwal S, Bergman A, Zhu T, Hackman F, Sathish JG, Updyke L, Loudon P, Krishna G, Clevenbergh P, Hernandez-Mora MG, Cisneros Herreros JM, Albertson TE, Dougan M, Thacker A, Baniecki ML, Soares H, Whitlock M, Nucci G, Menon S, Anderson AS, Binks M. Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Intravenous Infusions of PF-07304814 (Lufotrelvir) in Participants Hospitalized With COVID-19. Open Forum Infect Dis. 2023 Jul 10;10(8):ofad355. doi: 10.1093/ofid/ofad355. eCollection 2023 Aug.'}, {'pmid': '34541899', 'type': 'DERIVED', 'citation': 'Crosas-Molist E, Samain R, Kohlhammer L, Orgaz JL, George SL, Maiques O, Barcelo J, Sanz-Moreno V. Rho GTPase signaling in cancer progression and dissemination. Physiol Rev. 2022 Jan 1;102(1):455-510. doi: 10.1152/physrev.00045.2020. Epub 2021 Sep 20.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4611001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection.', 'detailedDescription': 'It is a 2-part study in hospitalized COVID-19 patients.\n\n* Part 1 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF-07304814 given as 24-hour IV infusion.\n\n 2 planned and 3 optional cohorts with 8 participants each are planned.\n* Part 2 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF- 07304814 given as 120-hour infusion.\n\n 2 planned and 2 optional cohorts with 8 participants each are planned'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n 1. Male or female participants between the ages of 18 and 79 years.\n 2. Confirmed SARS-CoV-2 infection.\n 3. Hospitalized for COVID-19.\n 4. Symptoms consistent with COVID-19 indicated by at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, new loss of taste and smell, nausea, chills, fatigue, rhinorrhea, diarrhea, vomiting or radiographic infiltrates by imaging consistent with COVID-19\n 5. Total body weight \\>=50 kg (110 lb), BMI \\<40 kg/m2; BMI \\<35 kg/m2 for 76- 79 years.\n* Exclusion Criteria:\n\n 1. Evidence of critical illness, defined by at least one of the following: Respiratory failure, Multi-organ dysfunction/failure, Cardiac failure or septic shock\n 2. Participants that are anticipated by the study Investigator to progress to critical disease, including mechanical ventilation, within 24 hours of enrolment\n 3. Participants with pre-existing moderate to severe cardiovascular disease, uncontrolled diabetes, or severe asthma or severe COPD.\n\n 3.Participants with a known medical history of recent acute or chronic liver disease (other than NASH), chronic or active hepatitis B or C infection, or primary biliary cirrhosis.\n\n 4.Participants with a known medical history of ischemic heart disease, heart failure, dysrhythmia or other pre-existing cardiac condition.\n\n 5\\. Participants with known HIV infection, acute or chronic history of hepatitis B or C.\n\n 6.Participants with a known medical history of recurrent seizures. 7. Participants with history of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism 8.Confirmed concurrent active systemic infection other than COVID-19. 9.Current diagnosis of cancer, unless in remission and untreated. 10.Other medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation 11.Females who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT04535167', 'briefTitle': 'First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1B, 2-PART, DOUBLE-BLIND, PLACEBO-CONTROLLED, SPONSOR-OPEN STUDY, TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE ASCENDING (24-HOUR, PART 1) AND MULTIPLE ASCENDING (120-HOUR, PART 2) INTRAVENOUS INFUSIONS OF PF-07304814 IN HOSPITALIZED PARTICIPANTS WITH COVID-19', 'orgStudyIdInfo': {'id': 'C4611001'}, 'secondaryIdInfos': [{'id': '2020-003905-73', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-07304814', 'description': 'Part 1:\n\nCohort 1-5\n\nPart 2:\n\nCohort 6-9', 'interventionNames': ['Drug: PF-07304814']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part 1:\n\nCohort 1-5\n\nPart 2:\n\nCohort 6-9', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-07304814', 'type': 'DRUG', 'description': 'PF-07304814 is an anti-viral, formulated for intravenous delivery', 'armGroupLabels': ['PF-07304814']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be formulated for intravenous delivery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Health', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Health Investigational Drug Pharmacy', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Translational and Clinical Research Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital, Clinical Trials Pharmacy', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Regional One Health', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'University Hospital Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '30150221', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Santa Casa De Misericórdia de Belo Horizonte', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}