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 |
|---|---|---|---|---|---|---|---|---|
| Alternate Antihypertensive (Pre RAS Blockade Washout Period) | Patients underwent screening visits and continued their original antihypertensive regimens before they entered the washout period. | 0 | None | 0 | 28 | 0 | 28 | View |
| Alternate Antihypertensive (RAS Blockade Washout Period) | In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure. The goal for their blood pressure will be set at \< 140/90 mm/Hg. The washout period will last for four weeks at the end of which the patient will enter the test period. amlodipine, hydralazine, terazosin or hydrochlorothiazide: In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure. | 0 | None | 0 | 28 | 0 | 28 | View |
| Alternate Antihypertensive (Post RAS Blockade Washout Period) | Patients were restarted on their original antihypertensive medication which they were taking when they entered the study | 0 | None | 0 | 28 | 0 | 28 | View |