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 @ 4:48 PM
Ignite Modification Date: 2025-12-25 @ 2:33 PM
NCT ID: NCT01528150
Description: None
Frequency Threshold: 0
Time Frame: Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.
Study: NCT01528150
Study Brief: Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Accent MRI System Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads None None 174 466 78 466 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac/Venous Perforation SYSTEMATIC_ASSESSMENT Vascular disorders None View
Device migration SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Exacerbation of Diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Exacerbation of heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Helix issue SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
hematoma/bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Impedance out of range SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
lead dislodgement or migration SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Muskuloskeletal event SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lead replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
neoplastic disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
neurological event SYSTEMATIC_ASSESSMENT Nervous system disorders None View
other various SYSTEMATIC_ASSESSMENT Investigations None View
Other Cardiac/cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other lead related SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pneumothorax/hemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary events SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
renal event SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased right ventricular sensing SYSTEMATIC_ASSESSMENT Investigations None View
exacerbation of heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hematoma/bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
impedance out of range SYSTEMATIC_ASSESSMENT Investigations None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
musculoskeletal event SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
neurological event SYSTEMATIC_ASSESSMENT Nervous system disorders None View
other cardio/cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other lead related SYSTEMATIC_ASSESSMENT Investigations None View
Pacemaker software issue SYSTEMATIC_ASSESSMENT Investigations None View
arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
device programming SYSTEMATIC_ASSESSMENT Investigations None View
lead noise SYSTEMATIC_ASSESSMENT Investigations None View
other various SYSTEMATIC_ASSESSMENT Investigations None View
pulmonary event SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View