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
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:13 AM
NCT ID:
NCT03490734
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse data were collected for the duration (beginning to end) of each of the 4 study assessments (pre-intervention baseline visit, pre-intervention scan visit, post-intervention scan visit, post-intervention behavioral visit) and for the duration of the intervention (21 days), an average of 25 days.
Study:
NCT03490734
Study Brief:
Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Beverage A (Sweetened) | One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a tasteless beverage solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. Black Cherry and Orange Flavored Beverage with added sugar: 10 oz daily for three weeks Tasteless Beverage: A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure. | 0 | None | 0 | 47 | 2 | 47 | View |
| Beverage B (Sweetened) | One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage with added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a tasteless beverage solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. Strawberry Kiwi \&Lemonade Flavored Beverage with added sugar: 10 oz daily for three weeks Tasteless Beverage: A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure. | 0 | None | 0 | 38 | 0 | 38 | View |
| Beverage A (Unsweetened) | One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a tasteless beverage solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. Black Cherry and Orange Flavored Beverage no added sugar: 10 oz daily for three weeks Tasteless Beverage: A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure. | 0 | None | 0 | 34 | 0 | 34 | View |
| Beverage B (Unsweetened) | One quarter of the group to receive strawberry kiwi \& lemonade flavored beverage no added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a tasteless beverage solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. Strawberry Kiwi \& Lemonade Flavored Beverage no added sugar: 10 oz daily for three weeks Tasteless Beverage: A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure. | 0 | None | 0 | 41 | 0 | 41 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nausea during fMRI scan | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |