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 |
|---|---|---|---|---|---|---|---|---|
| Active, then Sham rTMS | In this within-subject crossover design, participants first received 2 weeks of active TMS treatment at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. After a 4 week washout during which no TMS was administered, participants received 2 weeks of sham (placebo) TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA). | 0 | None | 0 | 8 | 0 | 8 | View |
| Sham, then Active rTMS | In this within-subject crossover design, participants first received 2 weeks of sham (placebo) TMS treatment. After a 4 week washout during which no TMS was administered, participants received 2 weeks of active TMS at a personalized intensity determined through a Motor Threshold assessment before the first day of TMS. All participants carry a diagnosis of Primary Progressive Aphasia (PPA). | 0 | None | 0 | 2 | 0 | 2 | View |