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:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
NCT ID:
NCT04817332
Description:
Adverse events were reported by the participant, site principal investigators or delegated staff responsible for detecting documenting and recording events that met the definition of an adverse event. Participants discharged from hospital before the end of the trial were given a diary to record adverse events up to day 28. Site principal investigators were responsible for assigning seriousness and causality of AEs
Frequency Threshold:
0
Time Frame:
29 days
Study:
NCT04817332
Study Brief:
STOP-COVID19: Superiority Trial Of Protease Inhibition in 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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Placebo oral tablet, 25mg once per day for 28 days Placebo: Matched placebo | 23 | None | 35 | 214 | 99 | 214 | View |
| Brensocatib | Brensocatib oral tablet, 25mg once per day for 28 days Brensocatib: Selective, competitive, and reversible inhibitor of DPP1 | 29 | None | 40 | 192 | 86 | 192 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| General disorders | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Respiratory disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Neoplasms | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Skin disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chronic lymphocytic leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Cold sweat | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Hallucination, visual | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Nightmare | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Electrocardiogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Glycosylated haemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Blood glucose abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Tachyarrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gastritis erosive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Oral mucosal eruption | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Glossodynia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Tongue blistering | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Oral mucosal blistering | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Swollen tongue | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Hypoaesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Lip pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Lip swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Paraesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Tongue erythema | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Tongue discolouration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.0) | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Subcutaneous emphysema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Vulvovaginal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Serratia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |
| Steroid diabetes | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |