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 |
|---|---|---|---|---|---|---|---|---|
| Roll-in Study Phase: RF Ablation | Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve. | 0 | None | 1 | 8 | 0 | 8 | View |
| Main Study Phase: RF Ablation | RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system). | 0 | None | 2 | 87 | 0 | 87 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lumbar vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Sternal fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Major Vascular Access Complication/ Bleeding | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| ST-elevation myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |