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 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT01996033
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01996033
Study Brief: EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Full Cohort All subjects - this is a single arm study 1 None 5 25 4 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Prostate Disease NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Arterial Hypertension/Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Multiple Organ Failure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertensive Crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
VASC Vessel Stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arterial Hypertension/Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abnormal Lab Value (Suspicion of Cholangitis) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal Artery Stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View