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 |
|---|---|---|---|---|---|---|---|---|
| 10 mg Adefovir Dipivoxil (ADV) | 10 mg ADV tablets once daily for 104 weeks | None | None | 5 | None | 38 | None | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neurilemmoma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Bronchitis chronic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Cerebral hemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Hepatitis B | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Hepatic neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |