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 Group | Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA) sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions. | None | None | 0 | 23 | 6 | 23 | View |
| PTSD With no History of TBI | Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen. | None | None | 0 | 0 | 0 | 0 | View |
| Standard TBI Care | Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) | None | None | 0 | 0 | 0 | 0 | View |
| HBO2 Group | Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions. The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute). | None | None | 0 | 24 | 8 | 24 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| mild ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Tooth pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Inner ear barotrauma | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Onset migraine headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Increase frequency and intensity of headaches | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Transient worsening of myopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Change in headache frequency | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Claustrophobia/anxiety | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sinus pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |