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 |
|---|---|---|---|---|---|---|---|---|
| Liposomal Amphotericin B: 3 mg/kg | 3 mg/kg intravenously (IV) three times per week | None | None | 5 | 39 | 0 | 39 | View |
| Liposomal Amphotericin B: 9 mg/kg | 9 mg/kg IV once per week | None | None | 2 | 33 | 0 | 33 | View |
| Voriconazole: 400 mg | 400 mg oral twice daily day 1 followed by 200 mg twice daily | None | None | 4 | 40 | 0 | 40 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Supravnetricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Allergic Reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Acute Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Infection Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Elevated alanine aminotransferase | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |