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 |
|---|---|---|---|---|---|---|---|---|
| Transfusion Group | The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months. | None | None | 6 | 99 | 99 | 99 | View |
| Observation Group | The observation Group received standard care therapy and quarterly physical examination by a study hematologist for 36 months. | None | None | 16 | 97 | 97 | 97 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vaso-Occlusive Pain | None | General disorders | None | View |
| Acute Chest Syndrome | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Priapism | None | General disorders | None | View |
| Symptomatic avascular necrosis of the hip | None | General disorders | None | View |
| Headache | None | General disorders | None | View |
| Blood-transfusion reaction | None | General disorders | None | View |
| Ferritin > 1500 ng/ml | None | General disorders | None | View |