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 |
|---|---|---|---|---|---|---|---|---|
| Baseline for Calorie/Control Poster | We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school. | 0 | None | 0 | 167 | 0 | 167 | View |
| Baseline for SSB Warning and Non-SSB Promotion Poster | We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school. | 0 | None | 0 | 145 | 0 | 145 | View |
| Calorie/Control Poster | This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. It will simply state that those beverages are sold in the school store. Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages | 0 | None | 0 | 143 | 0 | 143 | View |
| SSB Warning and Non-SSB Promotion Poster | This poster will display images of both Sugar Sweetened Beverages (SSBs) and low or no sugar beverages with calories listed below the beverages. In addition, the message will state that SSBs are high in sugar and should be avoided, while low or no sugar beverages are healthier options and should be chosen. Exposure to beverage health information: Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages | 0 | None | 0 | 173 | 0 | 173 | View |