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 |
|---|---|---|---|---|---|---|---|---|
| High Hemoglobin (Liberal) Group | High Hemoglobin group; goal Hb \>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion. | None | None | 0 | 30 | 0 | 30 | View |
| Low Hb (Restrictive) Group | Low Hb transfusion group; RBCs are not transfused unless the Hb \<9.0 g/dl and clinical indications for transfusion are met. | None | None | 0 | 30 | 0 | 30 | View |