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: 2025-12-24 @ 9:09 PM
Ignite Modification Date: 2025-12-25 @ 7:00 PM
NCT ID: NCT02939404
Description: None
Frequency Threshold: 1
Time Frame: 1 year
Study: NCT02939404
Study Brief: Food Intake Response to Short-Term Modifications of Metabolism in Humans
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chamber at 19°C With Fixed Diet First Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting. Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C Fixed diet: A diet that matches the participant's caloric needs Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat) 0 None 0 24 2 24 View
2. Chamber at 19°C, ad Libitum Diet First Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting. Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C Fixed diet: A diet that matches the participant's caloric needs Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat) 0 None 0 30 1 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroesophageal reflux disease symptoms at Chamber at 24°C, fixed diet NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease symptoms at Chamber at 19°C, fixed diet NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View