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 |
|---|---|---|---|---|---|---|---|---|
| Smart Phone Based Telemonitoring of HBP | 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP + enhanced usual care: Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary | None | None | 0 | 105 | 0 | 105 | View |
| Enhanced Usual Care | 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Enhanced usual care: Encouraged to do HBP measurement and record BP readings in paper diary | None | None | 0 | 105 | 0 | 105 | View |