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 |
|---|---|---|---|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days. | 0 | None | 0 | 31 | 2 | 31 | View |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days. | 0 | None | 0 | 29 | 0 | 29 | View |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days. | 0 | None | 0 | 30 | 2 | 30 | View |