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 |
|---|---|---|---|---|---|---|---|---|
| Coronary Angioplasty and Optimum Medical Therapy | Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques | 0 | None | 4 | 105 | 0 | 105 | View |
| Sham Procedure and Optimum Medical Therapy | Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques | 0 | None | 14 | 95 | 0 | 95 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Major bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Acute confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Crossover to PCI | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Wire snapped required snare retrieval | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalisation for atypical chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalisation for right heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalisation for leg pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Severe drug reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |