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 |
|---|---|---|---|---|---|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy. Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance. | 0 | None | 0 | 34 | 0 | 34 | View |
| MR-ultrasound Fusion | Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy. Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies. | 0 | None | 0 | 34 | 0 | 34 | View |
| Systematic Sampling | Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy. Systematic sampling is a probability sampling method in which a random sample, with a fixed periodic interval, is selected from a larger population. | 0 | None | 0 | 34 | 0 | 34 | View |