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
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest Pain (non cardiac) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| skin irritation from nasal CPAP mask | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Boil on Lip | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Drowsy Driving | SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Claustrophobia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Skin irritation from echocardiogram leads | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |