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 |
|---|---|---|---|---|---|---|---|---|
| Randomized to Alcohol Content | Each intervention had identical structure and length (2 hours for intervention, 1 hour for assessments). | 0 | None | 0 | 143 | 0 | 143 | View |
| Sex Plus Alcohol Risk Reduction | Corresponding intervention gives info focusing on sex and alcohol risk reduction only SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH): Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussio | 1 | None | 0 | 155 | 0 | 155 | View |
| Sexual + Alcohol + Cannabis Content | Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION: Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion | 0 | None | 0 | 162 | 0 | 162 | View |