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 |
|---|---|---|---|---|---|---|---|---|
| tDCS (Active) | Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current Cognitive Behavioral Therapy for Pain: Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. Transcranial Direct Current Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current | 1 | None | 0 | 65 | 2 | 65 | View |
| tDCS (Sham) | Inactive (sham) Transcranial Direct Current Stimulation Cognitive Behavioral Therapy for Pain: Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex | 0 | None | 0 | 51 | 0 | 51 | View |