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 |
|---|---|---|---|---|---|---|---|---|
| CSSP Toothpaste | Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds. | 0 | None | 0 | 132 | 2 | 132 | View |
| Fluoride Toothpaste | Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds. | 0 | None | 0 | 131 | 4 | 131 | View |