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 |
|---|---|---|---|---|---|---|---|---|
| Ozone Treatment and Placebo Treatment | Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randominzed to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds. | None | None | 5 | 394 | 0 | 394 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Surgery ovarian cyst removal | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| surgery breast reduction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Broken left leg | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Broken left knee | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |