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 |
|---|---|---|---|---|---|---|---|---|
| High Dose - SkQ1 | SkQ1 High Dose ophthalmic solution | 0 | None | 2 | 151 | 3 | 151 | View |
| SkQ1 Vehicle | Vehicle for SkQ1 ophthalmic solution | 0 | None | 1 | 151 | 3 | 151 | View |
| Low Dose - SkQ1 | SkQ1 Low dose ophthalmic solution | 0 | None | 3 | 149 | 4 | 149 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ovarian cancer | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Peripheral arterial occlusive disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |