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 @ 6:33 PM
Ignite Modification Date: 2025-12-25 @ 4:03 PM
NCT ID: NCT03828357
Description: None
Frequency Threshold: 0
Time Frame: from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
Study: NCT03828357
Study Brief: China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ellipse VR With Durata Ellipse VR single-chamber ICD with a Durata defibrillation lead Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T. 0 None 2 14 0 14 View
Ellipse DR With Durata & Tendril STS Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA). Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T. 0 None 3 14 0 14 View
Ellipse DR With Optisure and Isoflex Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA). Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T. 0 None 2 15 1 15 View
Quadra Assura MP CRT-D Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T. 0 None 1 12 0 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
OTHER: CERVICAL SPONDYLOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
OTHER:HEART FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
OTHER:Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
OTHER: CAROTID SCLEROSIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
OTHER: HYPERKALEMIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
OTHER: DILATED CARDIOMYOPATHY SYSTEMATIC_ASSESSMENT Cardiac disorders None View
OTHER:INAPPROPIATE SHOCK SYSTEMATIC_ASSESSMENT Product Issues None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
OTHER: VENTRICULAR FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View