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 |
|---|---|---|---|---|---|---|---|---|
| Physician Management | PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma. Buprenorphine: buprenorphine/naloxone Physician Management: Brief physician counseling | 0 | None | 0 | 30 | 0 | 30 | View |
| CBT for POD | Integrated cognitive behavioral therapy for chronic pain and opioid dependence CBT: Cognitive behavioral therapy Buprenorphine: buprenorphine/naloxone | 0 | None | 0 | 30 | 0 | 30 | View |
| Educational Counseling for POD | Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM) Buprenorphine: buprenorphine/naloxone Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians | 0 | None | 0 | 30 | 0 | 30 | View |