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 |
|---|---|---|---|---|---|---|---|---|
| Randomized Meniscectomy | This group will have a partial meniscectomy Meniscectomy: Arthroscopic meniscectomy | 0 | None | 0 | 4 | 0 | 4 | View |
| Randomized Lavage | This group will have arthroscopy and lavage Arthroscopic Lavage: Arthroscopic Lavage | 0 | None | 0 | 3 | 0 | 3 | View |
| Standard of Care Meniscectomy Pre-Amendment | Pre-Amendment: surgeons determined standard of care option, meniscectomy, best benefited the patient. | 0 | None | 0 | 9 | 0 | 9 | View |
| Standard of Care Meniscectomy Post Amendment | Post Amendment: patients received a meniscectomy as a standard of care and were observed for 24-months post-operative. | 0 | None | 2 | 11 | 1 | 11 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rheumatoid Arthritis | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |