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 |
|---|---|---|---|---|---|---|---|---|
| Music Therapy Group | Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad. Music Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad. | 0 | None | 0 | 20 | 0 | 20 | View |
| Music Listening Group | Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist. Music Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist. | 0 | None | 0 | 20 | 0 | 20 | View |
| Control Group | Patient receives standard care and waits in treatment room/bay for twenty minutes. | 0 | None | 0 | 20 | 0 | 20 | View |