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 |
|---|---|---|---|---|---|---|---|---|
| QTc Meter | Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS. | 0 | None | 0 | 28 | 0 | 28 | View |
| QTc Meter - Healthy Controls | Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device. QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS. | 0 | None | 0 | 5 | 0 | 5 | View |