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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Placebo arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\]. Additional scales included the Headache Impact Test-6 24, total Pittsburgh Sleep Quality Index 25, Epworth Sleepiness Scale 26, and Self-Rated Anxiety Scale. 27 Subjects then underwent a baseline polysomnogram (PSG) and were excluded if no bruxism was identified, using standard criteria. | None | None | 0 | 10 | 8 | 10 | View |
| Botulinum Toxin Type A | Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\]. Additional scales included the Headache Impact Test-6 24, total Pittsburgh Sleep Quality Index 25, Epworth Sleepiness Scale 26, and Self-Rated Anxiety Scale. 27 Subjects then underwent a baseline polysomnogram (PSG) and were excluded if no bruxism was identified, using standard criteria. | None | None | 0 | 13 | 13 | 13 | View |