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 |
|---|---|---|---|---|---|---|---|---|
| Non-Operative Adverse Events | Rejuvenate Modular Stem/Neck. Non-operative site events are reported by participant. | 0 | None | 4 | 40 | 7 | 40 | View |
| Operative Adverse Events | Rejuvenate Modular Stem/Neck. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason. | 0 | None | 25 | 42 | 9 | 42 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Operative Site | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Operative Site | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Systemic Event | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Systemic Event | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Systemic Event | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Systemic Event | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Systemic Event | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Operative Site | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Operative Site | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |