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 |
|---|---|---|---|---|---|---|---|---|
| Meal Order 1 | Meal A will be served to participant in meal session 1 and Meal B in meal session 2. Dietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory Meal A: Turkey and Provolone Cheese Sandwich \[whole wheat bread 52g(female \& male), Turkey 70g(female) \& 133g(male), Provolone cheese 23g(female \& male), tomato 50g(female \& male), lettuce 45g(female \& male)\]; Chicken and wild rice \[chicken 98g(female \& male), wild rice 71g(female) \& 107g(male)\]; chocolate chips cookies \[44g(female) \& 60.5g(male)\]; potato chips \[39g(female) \& 52g(male)\]. Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory Meal B: Ham \& Cheddar cheese wrap \[Tortilla 45g(female \& male), Ham deli 76g(female) \& 103g(male), cheddar cheese 21g(female) \& 32g(male), Spring Mix 36g(female \& male), Fat Free ranch dressing 29g(female \& male)\]; Pasta with broccoli and Alfredo sauce \[Pasta 91g(female) \& 121g(male), Broccoli 66g(female \& male), Alfredo sauce 38g(female) \& 50g(male)\]; Chocolate Ice-cream \[107g(female), 138g(male)\]; Red seedless grapes \[365g (female), 471g(male)\]. | 0 | None | 0 | 15 | 0 | 15 | View |
| Meal Order 2 | Meal B will be served to participant in meal session 1 and Meal A in meal session 2. Dietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory Meal A: Turkey and Provolone Cheese Sandwich \[whole wheat bread 52g(female \& male), Turkey 70g(female) \& 133g(male), Provolone cheese 23g(female \& male), tomato 50g(female \& male), lettuce 45g(female \& male)\]; Chicken and wild rice \[chicken 98g(female \& male), wild rice 71g(female) \& 107g(male)\]; chocolate chips cookies \[44g(female) \& 60.5g(male)\]; potato chips \[39g(female) \& 52g(male)\]. Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory Meal B: Ham \& Cheddar cheese wrap \[Tortilla 45g(female \& male), Ham deli 76g(female) \& 103g(male), cheddar cheese 21g(female) \& 32g(male), Spring Mix 36g(female \& male), Fat Free ranch dressing 29g(female \& male)\]; Pasta with broccoli and Alfredo sauce \[Pasta 91g(female) \& 121g(male), Broccoli 66g(female \& male), Alfredo sauce 38g(female) \& 50g(male)\]; Chocolate Ice-cream \[107g(female), 138g(male)\]; Red seedless grapes \[365g (female), 471g(male)\]. | 0 | None | 0 | 15 | 0 | 15 | View |