Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
NCT ID:
NCT04535167
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.
Frequency Threshold:
5
Time Frame:
From pre-dose on Day 1 up to 41 days
Study:
NCT04535167
Study Brief:
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.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | 0 | None | 1 | 2 | 1 | 2 | View |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. | 0 | None | 0 | 2 | 1 | 2 | View |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion. | 0 | None | 1 | 2 | 2 | 2 | View |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion. | 0 | None | 1 | 2 | 2 | 2 | View |
| Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\~120 hours) continuous intravenous infusion. | 0 | None | 1 | 6 | 2 | 6 | View |
| Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\~120 hours) continuous intravenous infusion. | 0 | None | 2 | 7 | 3 | 7 | View |
| Part 2: Placebo 120-hours Continuous Infusion | Participants were enrolled in this arm and received placebo as 5-day (\~120 hours) continuous intravenous infusion. | 1 | None | 1 | 4 | 3 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | View |
| Subclavian vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.0 | View |
| COVID-19 pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.0 | View |
| Oliguria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.0 | View |
| Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.0 | View |
| Tympanic membrane perforation | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v24.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.0 | View |
| Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Infusion site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.0 | View |
| Tinea cruris | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.0 | View |
| Bronchitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.0 | View |
| COVID-19 pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.0 | View |
| Stoma site cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.0 | View |
| Haematocrit decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.0 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.0 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.0 | View |
| Fibrin D dimer increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | View |
| Sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.0 | View |