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 |
|---|---|---|---|---|---|---|---|---|
| Spironolactone | Experimental group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of spironolactone. Serum potassium and creatinine levels will be drawn at baseline, weeks 1,4,5 and months 3,6,9, and 12. If at week 4, serum potassium is \<5.5 mmol/L and serum creatinine-baseline creatinine is \<0.5 mg/dl, the study drug will be increased to the target dose of 50mg once daily for 12 months of follow-up. If a subject experiences an increase in serum potassium or creatinine above these parameters at week 4, the study drug will be decreased in half from current dosage. If on 25mg daily, subject will be instructed to decrease to 25mg every other day. Subjects who experience hyperkalemia or increased creatinine levels on 25mg every other day will have the drug discontinued. | 0 | None | 0 | 26 | 0 | 26 | View |
| Control Group | A control population of age and gender-matched volunteers recruited from the general medicine outpatient clinic at Tufts Medical Center as well as from Tufts Medical Center employees. Controls will be excluded if any history of heart disease or any risk factors for cardiovascular disease, conditions of physiological or pathological activation of collagen turnover. Control subjects will have a one time blood draw of 16mL (3 teaspoons). | 0 | None | 0 | 27 | 0 | 27 | View |