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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT01983293
Description: Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations. Complications: Adverse events that require invasive intervention. Observations: Adverse events that can be managed without invasive intervention.
Frequency Threshold: 0
Time Frame: Adverse Events were collected over a time period of 1 year from enrollment
Study: NCT01983293
Study Brief: CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
QLV Based Lead Implant In the QLV arm, the implanting physician assessed the QLV in at least two main branches of the coronary sinus for LV lead placement 9 None 8 128 31 128 View
Standard of Care In the control arm, investigators implanted the LV lead without the use of QLV measurements and instead used standard practices to identify the most suitable LV lead location 4 None 4 62 14 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding/Hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lead Dislodgement Or Migration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pneumothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Atrial Or Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac Perforation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Coronary Sinus Dissection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lead Fracture SYSTEMATIC_ASSESSMENT Product Issues None View
Therapy For Non-Ventricular Rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial Or Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bleeding/Hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Elevated Pacing Thresholds SYSTEMATIC_ASSESSMENT Product Issues None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Local Tissue Reaction; Formation Of Fibrotic Tissue SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Loss Of Capture SYSTEMATIC_ASSESSMENT Product Issues None View
Oversensing SYSTEMATIC_ASSESSMENT Product Issues None View
Phrenic Nerve/Diaphragmatic Stimulation SYSTEMATIC_ASSESSMENT Product Issues None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rise In Threshold And Exit Block SYSTEMATIC_ASSESSMENT Product Issues None View
Undersensing SYSTEMATIC_ASSESSMENT Product Issues None View
Other: Back Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Decompensated Systolic Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other: Desaturation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Device Insertion Site Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Device Insertion Site Pain (Intermittent) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Device Reset To Back Up Vvi SYSTEMATIC_ASSESSMENT Product Issues None View
Other: Device Site Burning (Intermittent) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Device Site Numbness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Device Site Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Device Site Redness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Diaphragm Stimulation While Lying Supine SYSTEMATIC_ASSESSMENT Product Issues None View
Other: Dysphagia SYSTEMATIC_ASSESSMENT General disorders None View
Other: Dysphagia And Dysguesia SYSTEMATIC_ASSESSMENT General disorders None View
Other: Elevated Lv Capture Threshold SYSTEMATIC_ASSESSMENT Product Issues None View
Other: Itching SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Left Clavicle Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Left Shoulder Discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Left Shoulder Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Left Upper Extremity Edema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other: Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Respiratory Insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other: Swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other: Worsening Heart Failure Due To Crt SYSTEMATIC_ASSESSMENT Cardiac disorders None View