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 |
|---|---|---|---|---|---|---|---|---|
| mLCI Imaging (Pilot) | Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. | 0 | None | 0 | 5 | 0 | 5 | View |
| mLCI Imaging (Jacobi) | Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type. | 0 | None | 0 | 50 | 0 | 50 | View |