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 |
|---|---|---|---|---|---|---|---|---|
| Sleep Hygiene & Yoga (SH+Y) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment). Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. Yoga intervention: Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks). | 0 | None | 0 | 16 | 8 | 16 | View |
| Sleep Hygiene (SH) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. | 0 | None | 0 | 17 | 6 | 17 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cellulitis (foot) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Mild rash (actigraph) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Back pain/spasm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Leg pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Root canal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Arm and chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Scratched cornea | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |