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 |
|---|---|---|---|---|---|---|---|---|
| TIME | This arm will receive the TIME intervention. TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews. | 0 | None | 12 | 22 | 2 | 22 | View |
| Treatment as Usual (TAU) | This arm will receive treatment as usual. | 0 | None | 1 | 22 | 0 | 22 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizures | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Heart condition | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Limb amputation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Blood Sugar | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Irritable Bowel Syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mini Stroke | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Circulatory Surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |