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 |
|---|---|---|---|---|---|---|---|---|
| L-DOPA | This trial entailed the administration of either L-DOPA or placebo in Step 1, followed by crossover to the other treatment assignment in Step 2 (i.e., L-DOPA followed by placebo or placebo followed by L-DOPA). Adverse events are grouped here by treatment assignment (L-DOPA or placebo). This arm pertains to the administration of L-DOPA in Step 1 and Step 2 of the study. | 0 | None | 0 | 4 | 3 | 4 | View |
| Placebo | This trial entailed the administration of either L-DOPA or placebo in Step 1, followed by crossover to the other treatment assignment in Step 2 (i.e., L-DOPA followed by placebo or placebo followed by L-DOPA). Adverse events are grouped here by treatment assignment (L-DOPA or placebo). This arm pertains to the administration of placebo in Step 1 and Step 2 of the study. | 0 | None | 0 | 3 | 2 | 3 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Increased blood pressure | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Faintness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |