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 |
|---|---|---|---|---|---|---|---|---|
| Rehabilitation | The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients. Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise | 0 | None | 0 | 13 | 0 | 13 | View |
| Low Lever Laser Acupuncture | The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz. Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect. | 0 | None | 0 | 13 | 0 | 13 | View |