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 |
|---|---|---|---|---|---|---|---|---|
| Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | 6 | None | 6 | 75 | 31 | 75 | View |
| Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. | 5 | None | 4 | 75 | 30 | 75 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Growth failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |