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 |
|---|---|---|---|---|---|---|---|---|
| I-CBT Feasibility Pilot | Open trial of I-CBT I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders. | 1 | None | 0 | 5 | 0 | 5 | View |
| RCT I-CBT | Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders. | 0 | None | 0 | 13 | 0 | 13 | View |
| RCT IDC | Randomized Controlled Trial: Individual Drug Counseling Arm IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence. | 0 | None | 0 | 13 | 0 | 13 | View |