Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:39 AM
Ignite Modification Date: 2025-12-25 @ 10:49 PM
NCT ID: NCT01172067
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01172067
Study Brief: QuickOpt Chronic Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Echocardiography Group the Echo Group patients will be optimized by Echo. Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography 15 None 19 194 6 194 View
Quickopt Group the QuickOpt Group patients will be optimized by QuickOpt(IEGM); Cardiac Resynchronization Therapy: Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation. 23 None 28 198 6 198 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hopitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure Deterioration; Death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiopulmonary arrest, death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Junctional rhythm, hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure deterioration, hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure deterioration, elevated left ventricular pacing threshold NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure deterioration, myocardial infarction, venous thrombosis, death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure deterioration, phrenic nerve stimulation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial ischemia, staged heart bypass surgery NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest distress, short breaths NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebral hemorrhage, death NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haematoma, low right atrial lead sensing NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pacemaker pocket ulceration NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pacemaker reject NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Phrenic nerve stimulation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated left ventricular pacing threshold NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary sinus dissection NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right ventricular lead dislocation/displacement NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right atrial lead dislocation/displacement NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular lead dislocation/displacement NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated pacing threshold of left ventricular lead; lead dislocation/displacem NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection at pacing system NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anaphylactic shock NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View