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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. Placebo: Placebo: 1200 mg per day for three months | None | None | 0 | 15 | 3 | 15 | View |
| Chlorogenic Acid | 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. Chlorogenic acid: Chologenic acid: 1200 mg per day for three months | None | None | 0 | 15 | 2 | 15 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | ANY | View |
| Headacha | SYSTEMATIC_ASSESSMENT | Nervous system disorders | ANY | View |
| polyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | ANY | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | ANY | View |
| abdominal distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | ANY | View |