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 |
|---|---|---|---|---|---|---|---|---|
| Intervention | The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). CBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). | 1 | None | 22 | 171 | 0 | 171 | View |
| No-treatment Control | Participants who are assigned to the control group will not receive the intervention. | 0 | None | 17 | 198 | 0 | 198 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stroke and other nervous system disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cardiac-related hospitalization | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| GI related hospitalization | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Respiratory related hospitalization | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Infection - hospitalization | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Accidents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| General -surgery due to pre-existing conditions | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Kidney failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| General hospitalization | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |