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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Protonics Knee Brace | All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion. Protonics Knee brace: Protonics Therapy Program is separated into three phases for a period of 4 weeks. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks. Subjects will be monitored for any and all adverse events including excessive Delayed Onset Muscle Soreness throughout the study during the three (3) phases of the . Protonics Neuromuscular repositioning Technique training, | 0 | None | 0 | 21 | 0 | 21 | View |
| Sport Cords | Resistive sports cord to resist knee flexion. Sports Cords: Sports Cord Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the sports cord gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.Subjects will be monitored for any and all adverse events including excessive Delayed Onset Muscle Soreness throughout the study during the three (3) phases of the Sport Cord training, | 0 | None | 0 | 20 | 0 | 20 | View |