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 |
|---|---|---|---|---|---|---|---|---|
| Fibrin Sealant - 60 Seconds | Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time | None | None | 4 | 26 | 4 | 26 | View |
| Fibrin Sealant - 120 Seconds | FS VH S/D 500 s-apr, 120 seconds polymerization time | None | None | 4 | 24 | 9 | 24 | View |
| Fibrin Sealant All - (60 + 120 Seconds) | All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time 2. FS VH S/D 500 s-apr, 120 seconds polymerization time | None | None | 8 | 50 | 13 | 50 | View |
| Control Group | Treatment of the study-suture line will be manual compression with surgical gauze pads. | None | None | 4 | 23 | 7 | 23 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vascular graft complication | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Vascular graft occlusion | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Wound | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Myocardial infarction | None | Cardiac disorders | MedDRA (Unspecified) | View |
| Ventricular fibrillation | None | Cardiac disorders | MedDRA (Unspecified) | View |
| Gastrointestinal haemorrhage | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Pulmonary oedema | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Peripheral vascular disorder | None | Vascular disorders | MedDRA (Unspecified) | View |
| Metabolic acidosis | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Graft thrombosis | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Incision site haematoma | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Incision site complication | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Incision site oedema | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Incision site erythema | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Oedema peripheral | None | General disorders | MedDRA (Unspecified) | View |
| Ventricular tachycardia | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Pyrexia | None | General disorders | MedDRA (Unspecified) | View |
| Anxiety | None | Psychiatric disorders | MedDRA (Unspecified) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |