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 @ 3:36 PM
Ignite Modification Date: 2025-12-25 @ 1:48 PM
NCT ID: NCT02653092
Description: participants were not at risk for mortality due the nature of intervention. The participants were monitored for AEs by the investigator.
Frequency Threshold: 0
Time Frame: The adverse events were collected over 6 years
Study: NCT02653092
Study Brief: Reprometabolic Syndrome Mediates Subfertility in Obesity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aim 1 Reproduction of the reproductive phenotype of obesity in Normal Weight Women (NWW) by: 1. infusing insulin and free fatty acids (FFAs) in short term experiments and measuring gonadotropin pulsatility and pituitary GnRH response; and 2. inducing a chronic model of the reprometabolic syndrome by administering a eucaloric diet that is relatively high in pro-inflammatory omega-6 fatty acids and low in anti-inflammatory omega-3 fatty acids (high fat diet; HFD) for one month while monitoring gonadotropin pulsatility and daily urinary reproductive hormone excretion. Insulin Intralipid Dextrose Heparin GnRH 0 None 0 13 1 13 View
Aim 2 Assessment of the gluco-regulatory and anti-lipolytic actions of insulin with a 2-stage, Hyperinsulinemic, Euglycemic Clamp (HEC) to evaluate both suppression of lipolysis and hepatic glucose production. Insulin Intralipid Dextrose Heparin GnRH Hyperinsulinemic Euglycemic Clamp 0 None 0 18 0 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache and Nausea NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View