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 @ 10:50 PM
NCT ID:
NCT02066467
Description:
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Frequency Threshold:
0
Time Frame:
Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit)
Study:
NCT02066467
Study Brief:
Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 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 |
|---|---|---|---|---|---|---|---|---|
| Heart Failure Patients | * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment | 54 | None | 338 | 838 | 452 | 838 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coronary venous dissection | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Device Deficiency | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac stimulation - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Infection (> 30 days post-implant) | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Integumentary | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Intermittent Claudication | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mitral regurgitation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other SVT (eg AVRT, AVNRT, EAT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Renal insufficiency - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abnormal laboratory values | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Adverse reaction - Allergic reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Adverse reaction - Hypotension | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Aortic regurgitation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Arterial/venous thrombolytic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Atrial fibrillation (AF) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cerebrovascular accident (CVA) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain - Ischemic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain - Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| COPD exacerbation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dislodgment - Elevated threshold - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Extracardiac stimulation- LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Multiple signs - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - No reported signs - RA | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - No reported signs - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - No reported signs -LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Unable to capture - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Unable to capture - RA | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Unable to capture - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Distal thromboemboli | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Elevated threshold - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated threshold - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Endocrine | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Erosion | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac stimulation - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Genitourinary | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Head, eyes, ears, nose, throat (HEENT) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Heart failure symptoms - Unspecified | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hematoma - Pocket (<= 30 days post-implant) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Immune | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Impedance > 2000 ohms - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy - Noise | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy - Other | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy - SVT | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy- NSR | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Mitral stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multiple heart failure symptoms | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multi-system failure | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Multi-system failure - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial perforation post-implant - RA | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Myocardial perforation post-implant - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Myocardial perforation with tamponade | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Myocardial perforation without tamponade | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nonsustained ventricular tachycardia (NSVT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other - Lead | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other - Lead - Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Other - PG system | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other - PG system - Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Other- Heart failure patient condition - Cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other- Patient condition - Non- cardiovascular | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oversensing - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Pacemaker-mediated tachycardia (PMT) | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral edema - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral vascular disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Physical trauma | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pleural effusion - Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pneumothorax - Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Post-surgical infection (<= 30 days post-implant) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Post-surgical pocket hemorrhage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Post-surgical wound discomfort | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Premature ventricular contractions (PVC) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Psychological | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pulmonary | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary edema - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary embolism (PE) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Renal | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Systemic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Thromboembolic events | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Transient ischemic attack (TIA) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Unable to capture - RA | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Venous occlusion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Ventricular fibrillation (VF) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular tachycardia (VT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Weight gain - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abnormal laboratory values | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Adverse reaction - General | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Adverse reaction - Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Aortic regurgitation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial fibrillation (AF) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Chest pain - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain - Ischemic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain - Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary venous dissection | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Device Deficiency | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Elevated threshold - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Elevated threshold -RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Multiple signs - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - No reported signs - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - No reported signs -LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Unable to capture - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Unable to capture - RA | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dislodgment - Undersensing - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Elevated threshold - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated threshold - RA | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Elevated threshold - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Endocrine | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Extracardiac stimulation - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Extracardiac stimulation - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Genitourinary | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Head, eyes, ears, nose, throat (HEENT) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Heart failure symptoms - Unspecified | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hematoma - Pocket (<= 30 days post-implant) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hematoma - Pocket (> 30 days post-implant) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hematoma - Unrelated to procedure or device | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypertension - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Impedance > 2000 ohms - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Impedance > 2000 ohms - RA | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Impedance > 2000 ohms - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate AV delay | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy - Other | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate tachy therapy - SVT | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Infection (> 30 days post-implant) | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Integumentary | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Multiple heart failure symptoms | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multiple symptoms | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nonsustained ventricular tachycardia (NSVT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other - Lead | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other - Lead - Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Other - PG system | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other - PG system - Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Other- Heart failure patient condition - Cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other- Patient condition - Non- cardiovascular | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Other SVT (eg AVRT, AVNRT, EAT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Oversensing - RV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Pacemaker-mediated tachycardia (PMT) | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pericarditis - Unrelated to procedure or device | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral edema - Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Physical trauma | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pleural effusion - Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pneumothorax - Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Post-surgical wound discomfort | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Premature ventricular contractions (PVC) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Psychological | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pulmonary | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rate response inappropriate | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Renal | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| RVAT Communication | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Thromboembolic events | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Transient ischemic attack (TIA) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Unable to capture - LV | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Vasovagal reaction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Venous occlusion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Ventricular fibrillation (VF) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular tachycardia (VT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |