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 |
|---|---|---|---|---|---|---|---|---|
| Placebo Group | 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds. | 0 | None | 0 | 0 | 0 | 0 | View |
| Experimental (Buddhify) Group | 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions. | 0 | None | 0 | 0 | 0 | 0 | View |
| Control Group | 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure | 0 | None | 0 | 0 | 0 | 0 | View |