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 |
|---|---|---|---|---|---|---|---|---|
| SFDI Measurement of Oxygen Saturation | Modulum: Modulim calibrated and set up ready for scanning. volar aspect of the thumb surface to target the optical camera head. oxygen parameters tissue oxygen, oxy-hemoglobin, deoxy-hemoglobin, superficial hemoglobin, and sub-surface hemoglobin. | 0 | None | 0 | 20 | 0 | 20 | View |
| PeriFlux 5000 for Transcutaneous Oxygen Partial Pressure | PeriFlux 5000: tcpO2 is a noninvasive, clinically-approved method to obtain skin oxygen levels. The method is quantitative and measures oxygen delivery to the skin from underlying tissue. The probe was heated to about 45 deg C. Although this device has other options, only the measurement of O2 will be performed using this device. | 0 | None | 0 | 20 | 0 | 20 | View |
| Apple Watch Oxygen Sensor for Arterial Oxygenation | Apple Watch Oxygen Sensor: Apple watch is equipped with green, red, and infrared LEDs that shine light onto the blood vessels in the wrist. This can measure blood oxygen levels between 70 and 100 percent. Most healthy people have blood oxygen levels that range from 95 to 100 percent. Apple watch sensor will be positioned on the user's preferred wrist. | 0 | None | 0 | 20 | 0 | 20 | View |
| A Pulse Oximeter for Arterial Oxygenation | Innovo iP 900AP: The pulse oximeter enables transcutaneous monitoring of the oxygen saturation of hemoglobin in arterial blood. In this study, volar aspect of thumb and index finder of the subject will be used to measure blood oxygen saturation. | 0 | None | 0 | 20 | 0 | 20 | View |