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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enalapril (Open-Label Extension Period) | Week 9 - 16: Sacubitril/Valsartan | 0 | None | 4 | 62 | 11 | 62 | View |
| Enalapril (Randomized Treatment Period) | Week 1 to Week 8: Enalapril | 1 | None | 4 | 70 | 26 | 70 | View |
| Sacubitril/Valsartan (Randomized Treatment Period) | Week 1 to Week 8: Sacubitril/Valsartan | 0 | None | 5 | 69 | 8 | 69 | View |
| Sacubitril/Valsartan (Open-Label Extension Period) | Week 9 - 16: Sacubitril/Valsartan | 0 | None | 3 | 64 | 11 | 64 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ischaemic cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Complication associated with device | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Incoherent | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Peripheral coldness | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |