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 |
|---|---|---|---|---|---|---|---|---|
| Standard Clinical Care (SCC ) | Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). | 0 | None | 0 | 7 | 0 | 7 | View |
| Standard Clinical Care and Varenicline (SCC + VT) | Participants received four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT). SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. | 0 | None | 0 | 7 | 5 | 7 | View |