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 |
|---|---|---|---|---|---|---|---|---|
| Study Group | Platelet Transfusion Management 1. Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35\*C, (the Sano or BT shunt clip is still on in children with SV physiology) 2. Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. 1. Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts 2. Subsequent platelet transfusion continued till completion via central venous access to the patient FFP and Cryoprecipitate: 1. 1 unit of cryoprecipitate administered during MUF and or after MUF as needed 2. FFP transfusion 10ml/kg during MUF and or after MUF as needed PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit \> 40 in neonates with SV physiology; Transfuse for Hematocrit\> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis | 0 | None | 0 | 21 | 3 | 21 | View |
| Control Group | Platelet Transfusion Management 1. Pre-Termination of CPB- No intervention 2. Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. 1. Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts 2. Subsequent platelet transfusion continued till completion via central venous access to the patient FFP and Cryoprecipitate: 1. 1 unit of cryoprecipitate administered during MUF and or after MUF as needed 2. FFP transfusion 10ml/kg during MUF and or after MUF as needed PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit \> 40 in neonates with SV physiology; Transfuse for Hematocrit\> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis | 0 | None | 4 | 21 | 6 | 21 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiopulmonary Resuscitation (CPR) Event | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |