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 |
|---|---|---|---|---|---|---|---|---|
| Latanoprost | One drop self-administered in the study eye(s) once daily for 90 days | None | None | 7 | 363 | 0 | 363 | View |
| Travoprost | One drop self-administered in the study eye(s) once daily for 90 days | None | None | 5 | 363 | 0 | 363 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coronary Artery Occlusion | None | Cardiac disorders | MedDRA (11.0) | View |
| Gastroesophageal Reflux Disease | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Convulsion | None | Nervous system disorders | MedDRA (11.0) | View |
| Atrial Fibrillation | None | Cardiac disorders | MedDRA (11.0) | View |
| Brachycardia | None | Cardiac disorders | MedDRA (11.0) | View |
| Coronary Artery Disease | None | Cardiac disorders | MedDRA (11.0) | View |
| Abdominal Pain | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Intestinal Obstruction | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Chest Pain | None | General disorders | MedDRA (11.0) | View |
| Diverticulitis | None | Infections and infestations | MedDRA (11.0) | View |
| Urinary Tract Infection | None | Renal and urinary disorders | MedDRA (11.0) | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Cerebrovascular accident | None | Nervous system disorders | MedDRA (11.0) | View |