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 |
|---|---|---|---|---|---|---|---|---|
| Dopamine D2/3 Receptor Antagonists | Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay. | 0 | None | 0 | 61 | 3 | 61 | View |