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 |
|---|---|---|---|---|---|---|---|---|
| Children 2-18 Months of Age | Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (\<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation. | None | None | 0 | 100 | 0 | 100 | View |