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 |
|---|---|---|---|---|---|---|---|---|
| Experiment | In the second stage of labor, the birth mirror will be used to allow the mother to see her own perineum. Labor Mirror: The labor mirror used in the second stage of labor allows the mother and midwife to observe the descent and birth of the baby during vaginal delivery and provides instant visualization of progress for the mother and midwife, especially in water births or water births | 0 | None | 0 | 61 | 0 | 61 | View |
| Control | During the birth process, she will receive routine midwifery care and no intervention will be made. | 0 | None | 0 | 61 | 0 | 61 | View |