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 |
|---|---|---|---|---|---|---|---|---|
| Ritxumab | Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14. | None | None | 2 | 24 | 21 | 24 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic reaction to detergent on hand and arm | None | Immune system disorders | None | View |
| Hot/cold flashes | None | General disorders | None | View |
| Contact dimities | None | Skin and subcutaneous tissue disorders | None | View |
| Edema | None | Vascular disorders | None | View |
| Excessive vaginal bleeding | None | Reproductive system and breast disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Deep venous thrombosis | None | Vascular disorders | None | View |
| Leg small vessel bursting | None | Vascular disorders | None | View |
| Spider veins | None | Vascular disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Sinus headache | None | Immune system disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Endometriosis | None | Reproductive system and breast disorders | None | View |
| Insomnia | None | Nervous system disorders | None | View |
| Hair loss | None | Skin and subcutaneous tissue disorders | None | View |
| Fall | None | General disorders | None | View |
| Lacerated forehead | None | Injury, poisoning and procedural complications | None | View |
| Hiatal hernia | None | Gastrointestinal disorders | None | View |
| Corrective surgery, hammer toes | None | Surgical and medical procedures | None | View |