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 |
|---|---|---|---|---|---|---|---|---|
| Prazosin | 1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness). 2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h). 3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h. 4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h. 5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later. 6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later. If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring. Prazosin: Participants in this arm will receive the study drug as outlined in the arm description. | 0 | None | 0 | 3 | 1 | 3 | View |
| Standard of Care | Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care. | 0 | None | 0 | 2 | 1 | 2 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| dizziness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| urinary urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypoxia during the night | SYSTEMATIC_ASSESSMENT | General disorders | None | View |