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 @ 2:07 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT01831895
Description: None
Frequency Threshold: 1
Time Frame: Adverse event data were collected through study completion (3 years).
Study: NCT01831895
Study Brief: Controlling and Lowering Blood Pressure With The MOBIUSHD™
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MobiusHD™ MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension. 1 None 1 17 7 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension - acute SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain - puncture site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abnormal lab finding - hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Digestive system disorder - vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Access site complication - hemorrhage - groin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain - head NON_SYSTEMATIC_ASSESSMENT General disorders None View
Access site complications - postprocedural NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anesthesia complications - blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Arrhythmia - Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Digestive system disorder - nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension - acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Respiratory Abnormalities - Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View