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 |
|---|---|---|---|---|---|---|---|---|
| CLASP-A Intervention | Adolescent participants and parents will receive adjunctive psychosocial intervention. CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan. | None | None | 11 | 19 | 0 | 19 | View |
| Treatment as Usual | Adolescent participants and parents will not receive study intervention Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning. | None | None | 9 | 23 | 0 | 23 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ED for drug overdose | None | Psychiatric disorders | None | View |
| Suicide attempt | None | Psychiatric disorders | None | View |
| Hospitalization for suicidal ideation | None | Psychiatric disorders | None | View |
| ED visit for suicidal ideation | None | Psychiatric disorders | None | View |
| ED for medical evaluation (e.g. frostbite) | None | Skin and subcutaneous tissue disorders | None | View |
| Legal Issues | None | Social circumstances | None | View |