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 |
|---|---|---|---|---|---|---|---|---|
| Healthy Pregnancy | Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM. | 0 | None | 0 | 10 | 0 | 10 | View |
| Pregnant Mothers With Gestational Diabetes | GDM was defined as a positive glucola screen at 26 to 32 weeks gestation. | 0 | None | 0 | 5 | 0 | 5 | View |
| Pregnant Mothers With Infants Diagnosed With IUGR | IUGR was defined as fetal weight and abdominal circumference \<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes | 0 | None | 0 | 5 | 0 | 5 | View |