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 @ 2:59 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT01773733
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01773733
Study Brief: The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary 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
Obese Patients 18-65 y.o.with alimentary obesity, BMI (Body Mass Index) ≥ 30 kg/m2) 0 None 0 56643 2322 56643 View
Overweight & Risk Factors Patients 18-65 y.o., overweight, BMI ≥ 27 kg/m 2 plus T2DM ( type 2 diabetes mellitus) or dyslipidemia 0 None 0 13167 540 13167 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypertension/increased blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Other Adverse Events SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View