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 |
|---|---|---|---|---|---|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control. Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control. Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control. Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control. | 201 | None | 83 | 805 | 0 | 805 | View |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units). Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units). Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control. Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control. Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control. Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control. | 192 | None | 84 | 799 | 0 | 799 | View |