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 |
|---|---|---|---|---|---|---|---|---|
| HES 130/0.4 (Voluven) | 6% HES 130/0.4 during surgery HES 130/0.4 (Voluven) | 0 | None | 17 | 69 | 0 | 69 | View |
| Human Albumin 5% | human albumin 5% during surgery human albumin 5% | 2 | None | 12 | 72 | 0 | 72 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| cardiac-related | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Nervous disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| respiratory related event | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |