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 |
|---|---|---|---|---|---|---|---|---|
| Xylitol | A half of the subjects (n = 37) were randomly allocated into xylitol group. Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w. None of the subjects had any adverse effects of the consumption of the chewing gum. | None | None | 0 | 35 | 0 | 35 | View |
| Sorbitol | A half of the subjects (n = 38) were randomly allocated into sorbitol group. Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%. None of the subjects had any adverse effects of the consumption of the chewing gum. | None | None | 0 | 38 | 0 | 38 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |