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 |
|---|---|---|---|---|---|---|---|---|
| Exercise Training Group | * Aerobic exercise * Resistance exercise (including pelvic floor muscle training with biofeedback) * Stretching exercise * Home exercise Multimodal exercise training: A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety. A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction. | 0 | None | 0 | 14 | 0 | 14 | View |
| Control Group | ●Usual care After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements. Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation. | 0 | None | 0 | 13 | 0 | 13 | View |