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 |
|---|---|---|---|---|---|---|---|---|
| Group Study | The 40 patients enrolled were 50% men and 50% women. The average age was 64.5 years. The median of the comorbidities presented by the participants was two, and in 33% (n = 13) of the cases there were more than 2 comorbidities per patient. Based on the staging of diabetic disease, the enrolled population was made up as follows: * reduced glucose tolerance 15% * impaired fasting blood sugar 5% * type 2 diabetes free of organ complications 38% * type 2 diabetes with chronic complications 42% | 0 | None | 0 | 40 | 0 | 40 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Description | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Not Serious Adverse Event | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |