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 |
|---|---|---|---|---|---|---|---|---|
| 1-MET/CBT/CM | Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM) Psychotherapy : Nine session treatment (wks 1-8 and wk 12) 2x/wk urine drug testing Contingency Management voucher program | None | None | 0 | 29 | 0 | 29 | View |
| 2-cMET/CBT/CM | Computer-delievered (c) MET/CBT/CM treatment Computerized Psychotherapy : Nine session computer delivered treatment 2 times per week urine drug testing | None | None | 0 | 30 | 0 | 30 | View |
| 3-tMET | Motivational enhancement therapy Motivational enhancement therapy : Two session treatment 2x/wk urine drug testing non-contingent vouchers | None | None | 0 | 16 | 0 | 16 | View |