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 |
|---|---|---|---|---|---|---|---|---|
| SoC Plus Hearing-aid Informational Guide | standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids Hearing-Aid Informational Guide: Printed take-home guide on hearing aids Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist | 0 | None | 1 | 59 | 0 | 59 | View |
| SoC Plus a Take-home DVD | standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids Hearing-Aid DVD: Take-home DVD about hearing aids Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist | 0 | None | 0 | 61 | 0 | 61 | View |
| SoC Plus Counseling With the Teach-back Technique | standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist | 0 | None | 0 | 63 | 0 | 63 | View |
| Standard of Care | standard of care hearing-aid orientation as provided by clinical audiologist Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist | 0 | None | 0 | 62 | 0 | 62 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Non-study-related adverse event | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |