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 |
|---|---|---|---|---|---|---|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) | All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food. | None | None | 19 | 557 | 25 | 557 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| suicidal ideation and/or attempt, bipolar disorder, or anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hypertension / Hypertensive crisis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Testicular torsion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Food allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |