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 |
|---|---|---|---|---|---|---|---|---|
| Active NIR-PBM | This condition involves baseline testing, 12 weeks of Near Infrared-Photobiomodulation (NIR-PBM), and post-intervention testing. Cognitive and neuroimaging outcomes are obtained before and after the intervention. The intervention consists of a) 16 laboratory sessions of NIR-PBM given 3 times/week for 2 weeks and then once weekly for 10 weeks and b) 44 home sessions of stimulation delivered intranasally. During each lab session, NIR light is delivered via placement of six MedX LED superluminous diode clusters over the scalp for a total of 40 minutes. Concurrently, two 810 Vielight intranasal devices are placed in each nostril for 25 min of total dose per nostril. During lab sessions, participants sit in front of a monitor and view nature documentaries (BBC Life series). This is done to standardize behavior during the intervention sessions. For home sessions, participants use a standalone 810 intranasal device only on weekdays when not completing a lab session. | 1 | None | 6 | 84 | 15 | 84 | View |
| Sham NIR-PBM | Participants randomized to the Sham control group will undergo identical procedures as the Active group. The only difference is that the "sham" NIR devices are modified not to deliver stimulation. Because NIR is invisible, participants are unable to detect whether NIR is being delivered. Sham NIR-PBM: The MedX sham and Vielight interventions device are identical in all respects to the active device, except that the MedX console and diode clusters were modified to NOT deliver NIR light when turned on. The sham MedX devices were modified to deliver 'warmth', similar to that of the active devices. As with the active condition, a total of six sham interventions were given over a 12-week period, following the identical procedures described in the active condition | 0 | None | 5 | 84 | 9 | 84 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| dizziness and vomiting | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| lacrimal irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| hip and back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| appendicitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| fainting | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |