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 |
|---|---|---|---|---|---|---|---|---|
| Sham Low Level Laser | Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized. Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered. | None | None | 0 | 4 | 0 | 4 | View |
| Active Low Level Laser | Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group. | None | None | 0 | 7 | 0 | 7 | View |