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 |
|---|---|---|---|---|---|---|---|---|
| Umbilical Cord Milking - Neonate | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. Both participating hospitals were randomized to perform umbilical cord milking as the first intervention in the primary trial. | 0 | None | 0 | 106 | 0 | 106 | View |
| Early Cord Clamping - Neonate | The umbilical cord is clamped as early as possible and within 60 seconds of delivery. Both participating hospitals were randomized to perform early cord clamping as the second intervention in the primary trial. | 0 | None | 0 | 121 | 0 | 121 | View |