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 |
|---|---|---|---|---|---|---|---|---|
| Educational-Medical-Behavioral | Educational-Medical-Behavioral intervention includes education, fiber supplements \[Metamucil 1-4 packets (3.4-13.6 g)/day\], laxatives \[Mirilax 1-2 packets or 17-34 g/day\] or anti-diarrheal medication \[Imodium 1-4 mg/day\], pelvic floor muscle exercises \[100 10-second squeezes/day\], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments \[if needed\]. | None | None | 0 | 11 | 0 | 11 | View |
| Standard Care | Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\]. | None | None | 1 | 8 | 0 | 8 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Disability | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | FAERS | View |