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 |
|---|---|---|---|---|---|---|---|---|
| BLP Arm (Blue Light Phototherapy) | In this arm participants will receive 5 BLP sessions at 1 week intervals. The duration of each session will be approximately 20 minutes. At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. Blue light phototherapy: Blue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes. | 0 | None | 0 | 0 | 0 | 0 | View |
| MCT Arm (Microcurrent Therapy) | In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated. Microcurrent therapy: The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the statio | 0 | None | 0 | 0 | 0 | 0 | View |
| Combination of BLP and Microcurrent | In this arm participants will receive 5 BLP and 5 MCT sessions at 1 week intervals. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes. Combination of BLP and Microcurrent: Same devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes. | 0 | None | 0 | 0 | 0 | 0 | View |