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 |
|---|---|---|---|---|---|---|---|---|
| EVICEL® Fibrin Sealant (Human) | An adverse event (AE) was defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of the EVICEL® product. For the purpose of this protocol, an AE was any untoward medical occurrence in a study subject that may be related or possibly related to the EVICEL® product. The relatedness to EVICEL® was based on the investigator's assessment. In the original version of the protocol, the SAE definition did not require that the AE be related or possibly related to the treatment. This discrepancy with the AE definition resulted in the sites reporting non-EVICEL® related AEs and SAEs prior to the amended protocol implementation. | None | None | 22 | 300 | 23 | 300 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Groin abscess | None | Infections and infestations | None | View |
| Sepsis | None | Infections and infestations | None | View |
| Septic shock | None | Infections and infestations | None | View |
| Staphylococcal infection | None | Infections and infestations | None | View |
| Ateriovenous fistula site complication | None | Injury, poisoning and procedural complications | None | View |
| Eschar | None | Injury, poisoning and procedural complications | None | View |
| Graft thrombosis | None | Injury, poisoning and procedural complications | None | View |
| Vascular graft occlusion | None | Injury, poisoning and procedural complications | None | View |
| Vascular graft thrombosis | None | Injury, poisoning and procedural complications | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Cerebrovascular accident | None | Nervous system disorders | None | View |
| Paraplegia | None | Nervous system disorders | None | View |
| Renal failure acute | None | Renal and urinary disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Peripheral vascular disorder | None | Vascular disorders | None | View |
| Steal syndrome | None | Vascular disorders | None | View |
| Thrombosis | None | Vascular disorders | None | View |
| Venous thrombosis limb | None | Vascular disorders | None | View |
| Angina pectoris | None | Cardiac disorders | None | View |
| Bradycardia | None | Cardiac disorders | None | View |
| Cardiac arrest | None | Cardiac disorders | None | View |
| Cardio-respiratory arrest | None | Cardiac disorders | None | View |
| Cardiogenic shock | None | Cardiac disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vascular graft occlusion | None | Injury, poisoning and procedural complications | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Steal Syndrome | None | Vascular disorders | None | View |
| Nodal rhythm | None | Cardiac disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Graft infection | None | Infections and infestations | None | View |
| Arteriovenous fistula thrombosis | None | Injury, poisoning and procedural complications | None | View |
| Urine analysis abnormal | None | Investigations | None | View |
| Fluid overload | None | Metabolism and nutrition disorders | None | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | None | View |
| Haematuria | None | Renal and urinary disorders | None | View |
| Urethral stenosis | None | Renal and urinary disorders | None | View |
| Erythema | None | Skin and subcutaneous tissue disorders | None | View |
| Arteriovenous fistula site complication | None | Injury, poisoning and procedural complications | None | View |