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 |
|---|---|---|---|---|---|---|---|---|
| Transabdominal Sonography | Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility. A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen. Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare. | 0 | None | 0 | 317 | 0 | 317 | View |
| Transvaginal Sonography | Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility. Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina. Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare. | 0 | None | 0 | 312 | 0 | 312 | View |