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
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Irritability (moderate) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Nasal congestion/allergy symptoms | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Query absence seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Leg shaking | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Increased energy | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Worsening tics | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Panic attack (moderate) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |