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 |
|---|---|---|---|---|---|---|---|---|
| Biomechanical Exercise (BE) | The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). | None | None | 0 | 10 | 0 | 10 | View |
| Traditional Exercise (TE) | The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). | None | None | 0 | 11 | 0 | 11 | View |
| Meditation Control (M) | The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). | None | None | 0 | 10 | 0 | 10 | View |