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 @ 1:37 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT02037295
Description: All adverse events, including those observed by or reported to the research team, will be recorded. Serious unanticipated problems, Unanticipated Adverse Device Effects and serious protocol deviations, will be reported to the IRB and Clinical Director (CD) as soon as possible but not more than 7 days after the PI first learns of the event. Not serious unanticipated problems will be reported to the IRB and CD as soon as possible but not more than 14 days after the PI first learns of the event.
Frequency Threshold: 0
Time Frame: Through study completion, an average of 31 days
Study: NCT02037295
Study Brief: Investigation of the Gut Microbiota in Regulating Nutrient Absorption 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
Underfeeding Healthy volunteers assigned underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements 0 None 0 27 0 27 View
Vancomycin Healthy volunteers assigned Vancomycin: Vancomycin 125mg orally four times per day for 12 days 0 None 0 13 0 13 View
Placebo Healthy volunteers assigned Placebo oral tablet: Placebo pills orally four times per day for 12 days 0 None 0 14 0 14 View
Overfeeding Healthy volunteers assigned overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements 0 None 0 27 0 27 View
Serious Events(If Any):
Other Events(If Any):