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 @ 5:30 PM
Ignite Modification Date: 2025-12-24 @ 5:30 PM
NCT ID: NCT01733368
Description: None
Frequency Threshold: 1
Time Frame: 6 months after CRT implant
Study: NCT01733368
Study Brief: QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Quadripolar Left Ventricular Lead (Quartet Lead) Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead 6 None 50 198 15 198 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Calculous Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Atrial or Ventricular arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bleeding/Hematoma NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cardiac arrest and death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Exacerbacion of Heart Failulre NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Exacerbacion of Heart Failulre and Death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Malignant tumor NON_SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myocardial infartion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhabdomyolysis due to amiodarone and statins treatment NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
stroke NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac perforation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elevated Pacing Thresholds NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Infection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Lead Dislodgement NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Phrenic Nerve/Diaphragmatic/Extracardiac stimulation NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Sepsis and Death NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
carbon dioxide narcosis NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Coronary sinus dissection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Inappropriate ATP NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Nause and vomiting NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pain in the implant site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
phrenic nerve/diaphragmatic/extracardiac stimulation NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Upgrade of the device to DDD by adding atrial lead NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Shiver and physical discomfort during implant NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding/Hematoma NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View