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 |
|---|---|---|---|---|---|---|---|---|
| OMT + UST | Active osteopathic manipulation and active ultrasound therapy | None | None | 1 | 115 | 6 | 115 | View |
| Sham OMT + UST | Sham osteopathic manipulation and active ultrasound therapy | None | None | 2 | 118 | 5 | 118 | View |
| OMT + Sham UST | Active osteopathic manipulation and sham ultrasound therapy | None | None | 5 | 115 | 4 | 115 | View |
| Sham OMT + Sham UST | Sham osteopathic manipulation and sham ultrasound therapy | None | None | 1 | 107 | 3 | 107 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Any serious adverse event according to Food and Drug Administration definition | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Any other adverse event | SYSTEMATIC_ASSESSMENT | General disorders | None | View |