Adverse Events Module

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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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT03250234
Description: Hamstring cramping
Frequency Threshold: 5
Time Frame: 3 weeks
Study: NCT03250234
Study Brief: Carbohydrate Availability and microRNA Expression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adequate Carbohydrate Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion 0 None 0 12 1 12 View
Low Carbohydrate Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage. For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion 0 None 0 12 1 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hamstring Cramping SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View