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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines. | None | None | 0 | 17 | 0 | 17 | View |
| Multimodal Physical Therapy | Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist | None | None | 0 | 15 | 0 | 15 | View |