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 |
|---|---|---|---|---|---|---|---|---|
| 28-day Old RBCs | Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells Transfusion of 28-day stored red blood cells: Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells. | 0 | None | 0 | 10 | 0 | 10 | View |
| 42-day Old RBCs | Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells Transfusion of 42-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells. | 0 | None | 0 | 10 | 0 | 10 | View |
| 7-day Old RBCs | Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells Transfusion of 7-day stored red blood cells: Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells. | 0 | None | 0 | 10 | 0 | 10 | View |