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 |
|---|---|---|---|---|
| Colitis | None | Gastrointestinal disorders | None | View |
| Colitis ulcerative | None | Gastrointestinal disorders | None | View |
| Appendicitis | None | Infections and infestations | None | View |
| Bronchitis | None | Infections and infestations | None | View |
| Fallopian tube perforation | None | Injury, poisoning and procedural complications | None | View |
| Post procedural hemorrhage | None | Injury, poisoning and procedural complications | None | View |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | None | View |
| Radiculitis brachial | None | Nervous system disorders | None | View |
| Ectopic pregnancy | None | Pregnancy, puerperium and perinatal conditions | None | View |
| Asthma | None | Respiratory, thoracic and mediastinal disorders | None | View |