CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Cardiac disorders

The 30 CTCAE v6.0 adverse events in Cardiac disorders, with grades 1 to 5.

Aortic valve disease

Cardiac disorders
  1. G1Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imaging
  2. G2Asymptomatic; moderate regurgitation or stenosis by imaging
  3. G3Symptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical intervention
  4. G4Life-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)
  5. G5Death
Definition and note

DefinitionA disorder characterized by a defect in aortic valve function or structure.

MedDRA code (LLT): 10061589 · CTCAE v6.0 (NCI), original English text.

Asystole

Cardiac disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Intervention indicated; device (e.g., pacemaker)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia without cardiac electrical activity. Typically, this is accompanied by cessation of the pumping function of the heart.

MedDRA code (LLT): 10003586 · CTCAE v6.0 (NCI), original English text.

Atrial fibrillation

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Non-urgent medical intervention indicated; electrical cardioversion
  3. G3Symptomatic, urgent intervention indicated; device (e.g., pacemaker); ablation; new onset
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response due to multiple reentry circuits. The rhythm disturbance originates above the ventricles.

MedDRA code (LLT): 10003658 · CTCAE v6.0 (NCI), original English text.

Atrial flutter

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Non-urgent medical intervention indicated
  3. G3Symptomatic, urgent intervention indicated; device (e.g., pacemaker); ablation
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with organized rhythmic atrial contractions with a rate of 200-300 beats per minute. The rhythm disturbance originates in the atria.

MedDRA code (LLT): 10003662 · CTCAE v6.0 (NCI), original English text.

Atrioventricular block complete

Cardiac disorders
  1. G1Not applicable
  2. G2Non-urgent intervention indicated
  3. G3Symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker); new onset
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

MedDRA code (LLT): 10003673 · CTCAE v6.0 (NCI), original English text.

Atrioventricular block first degree

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Non-urgent intervention indicated
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a dysrhythmia with a delay in the time required for the conduction of an electrical impulse through the atrioventricular (AV) node beyond 0.2 seconds; prolongation of the PR interval greater than 200 milliseconds.

MedDRA code (LLT): 10003674 · CTCAE v6.0 (NCI), original English text.

Cardiac arrest

Cardiac disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by cessation of the pumping function of the heart.

MedDRA code (LLT): 10007515 · CTCAE v6.0 (NCI), original English text.

Cardiac disorders - Other, specify

Cardiac disorders
  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

MedDRA code (LLT): 10007541 · CTCAE v6.0 (NCI), original English text.

Chest pain - cardiac

Cardiac disorders
  1. G1Mild pain
  2. G2Moderate pain; pain on exertion; hemodynamically stable; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Pain at rest; cardiac catheterization; new onset cardiac chest pain; unstable angina; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by substernal discomfort due to insufficient myocardial oxygenation e.g., angina pectoris.

Navigational noteConsider Cardiac disorders: Myocardial infarction. Record final diagnosis/cause once determined.

MedDRA code (LLT): 10008481 · CTCAE v6.0 (NCI), original English text.

Heart failure

Cardiac disorders
  1. G1Mild symptoms; no initiation or intensification of treatment
  2. G2Outpatient initiation or intensification of treatment
  3. G3Hospitalization indicated
  4. G4Requiring inotropic support, mechanical circulatory support, or consideration of cardiac transplantation
  5. G5Death
Definition and note

DefinitionA disorder characterized by the inability of the heart to pump blood at an adequate volume to meet tissue metabolic requirements, or, the ability to do so only at an elevation in the filling pressure.

Navigational noteIf asymptomatic, consider Cardiac disorders: Left ventricular dysfunction.

MedDRA code (LLT): 10019279 · CTCAE v6.0 (NCI), original English text.

Left ventricular dysfunction

Cardiac disordersNew in v6.0
  1. G1Left ventricular ejection fraction (LVEF) ≥50% AND one or more of the following: 1) New relative decline in Global Longitudinal Strain (GLS) >15% from baseline 2) New rise in cardiac biomarkers
  2. G2LVEF 40 - 49% AND one or more of the following: 1) LVEF reduction by ≥10% 2) New relative decline in GLS >15% from baseline 3) New rise in cardiac biomarkers
  3. G3New LVEF reduction to <40%
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an ASYMPTOMATIC abnormality of cardiac function.

Navigational noteIf symptomatic, consider Cardiac disorders: Heart failure.

MedDRA code (LLT): 10049694 · CTCAE v6.0 (NCI), original English text.

Mitral valve disease

Cardiac disorders
  1. G1Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imaging
  2. G2Asymptomatic; moderate regurgitation or stenosis by imaging
  3. G3Symptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical intervention
  4. G4Life-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)
  5. G5Death
Definition and note

DefinitionA disorder characterized by a defect in mitral valve function or structure.

MedDRA code (LLT): 10061532 · CTCAE v6.0 (NCI), original English text.

Mobitz (type) II atrioventricular block

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Symptomatic and incompletely controlled medically, or require a device (e.g., pacemaker)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with relatively constant PR interval prior to the block of an atrial impulse. This is the result of intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles.

MedDRA code (LLT): 10027786 · CTCAE v6.0 (NCI), original English text.

Mobitz type I

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Symptomatic; medical intervention indicated
  3. G3Symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with a progressively lengthening PR interval prior to the blocking of an atrial impulse. This is the result of intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles.

MedDRA code (LLT): 10027787 · CTCAE v6.0 (NCI), original English text.

Myocardial infarction

Cardiac disorders
  1. G1Not applicable
  2. G2Asymptomatic; imaging or ECG features consistent with myocardial infarction which may be of uncertain age
  3. G3Hemodynamically stable AND detection of a rise and/or fall of Cardiac troponin values with at least 1 value above the 99th percentile URL AND at least 1 of the following: 1) Symptoms of myocardial ischemia; 2) New ischemic ECG changes; 3) Development of pathological Q waves; 4) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology; 5) Identification of a coronary thrombus by angiography
  4. G4Life-threatening consequences; hemodynamically UNstable AND detection of a rise and/or fall of Cardiac troponin values with at least 1 value above the 99th percentile URL AND at least 1 of the following: 1) Symptoms of myocardial ischemia; 2) New ischemic ECG changes; 3) Development of pathological Q waves; 4) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology; 5) Identification of a coronary thrombus by angiography
  5. G5Death
Definition and note

DefinitionA disorder characterized by gross necrosis of the myocardium; this is due to an interruption of blood supply to the area.

MedDRA code (LLT): 10028596 · CTCAE v6.0 (NCI), original English text.

Myocarditis

Cardiac disorders
  1. G1Asymptomatic with Lab or ECG findings only
  2. G2Symptoms with moderate activity or exertion
  3. G3Severe with symptoms at rest or with minimal activity or exertion; intervention indicated; new onset of symptoms
  4. G4Life-threatening consequences; urgent intervention indicated (e.g., continuous IV therapy or mechanical hemodynamic support); hemodynamically unstable requiring non-invasive or invasive ventilation; complete or high grade AV block; significant ventricular arrhythmia
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the muscle tissue of the heart.

MedDRA code (LLT): 10028606 · CTCAE v6.0 (NCI), original English text.

Palpitations

Cardiac disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Intervention indicated
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an unpleasant sensation of irregular and/or forceful beating of the heart.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10033557 · CTCAE v6.0 (NCI), original English text.

Paroxysmal atrial tachycardia

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Non-urgent medical intervention indicated
  3. G3Symptomatic, urgent intervention indicated; ablation
  4. G4Life-threatening consequences; incompletely controlled medically; cardioversion indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with abrupt onset and sudden termination of atrial contractions with a rate of 150-250 beats per minute. The rhythm disturbance originates in the atria.

MedDRA code (LLT): 10034040 · CTCAE v6.0 (NCI), original English text.

Pericardial effusion

Cardiac disorders
  1. G1Not applicable
  2. G2Asymptomatic effusion size small to moderate
  3. G3Effusion with physiologic consequences
  4. G4Life-threatening consequences; hospitalization
  5. G5Death
Definition and note

DefinitionA disorder characterized by fluid collection within the pericardial sac, usually due to inflammation.

Navigational noteConsider Cardiac disorders: Pericardial tamponade, Pericarditis.

MedDRA code (LLT): 10034474 · CTCAE v6.0 (NCI), original English text.

Pericardial tamponade

Cardiac disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an increase in intrapericardial pressure due to the collection of blood or fluid in the pericardium.

Navigational noteConsider Cardiac disorders: Pericarditis.

MedDRA code (LLT): 10053565 · CTCAE v6.0 (NCI), original English text.

Pericarditis

Cardiac disorders
  1. G1Asymptomatic, ECG or physical findings (e.g., rub) consistent with pericarditis
  2. G2Symptomatic pericarditis (e.g., chest pain)
  3. G3Pericarditis with physiologic consequences (e.g., pericardial constriction)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by irritation to the layers of the pericardium (the protective sac around the heart).

MedDRA code (LLT): 10034484 · CTCAE v6.0 (NCI), original English text.

Pulmonary valve disease

Cardiac disorders
  1. G1Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis by imaging
  2. G2Asymptomatic; moderate regurgitation or stenosis by imaging
  3. G3Symptomatic; severe regurgitation or stenosis by imaging; symptoms controlled with medical intervention
  4. G4Life-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)
  5. G5Death
Definition and note

DefinitionA disorder characterized by a defect in pulmonary valve function or structure.

MedDRA code (LLT): 10061541 · CTCAE v6.0 (NCI), original English text.

Sick sinus syndrome

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Symptomatic, intervention not indicated; change in medication initiated
  3. G3Symptomatic, intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with alternating periods of bradycardia and atrial tachycardia accompanied by syncope, fatigue and dizziness.

MedDRA code (LLT): 10040639 · CTCAE v6.0 (NCI), original English text.

Sinus bradycardia

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Symptomatic, intervention not indicated; change in medication initiated
  3. G3Symptomatic, intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the sinus node.

MedDRA code (LLT): 10040741 · CTCAE v6.0 (NCI), original English text.

Sinus tachycardia

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Symptomatic; non-urgent medical intervention indicated
  3. G3Urgent medical intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates in the sinus node.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10040752 · CTCAE v6.0 (NCI), original English text.

Supraventricular tachycardia

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Non-urgent medical intervention indicated
  3. G3Symptomatic, urgent intervention indicated
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates above the ventricles.

MedDRA code (LLT): 10042604 · CTCAE v6.0 (NCI), original English text.

Tricuspid valve disease

Cardiac disorders
  1. G1Asymptomatic valvular thickening with or without mild valvular regurgitation or stenosis
  2. G2Asymptomatic; moderate regurgitation or stenosis by imaging
  3. G3Symptomatic; severe regurgitation or stenosis; symptoms controlled with medical intervention
  4. G4Life-threatening consequences; urgent intervention indicated (e.g., valve replacement, valvuloplasty)
  5. G5Death
Definition and note

DefinitionA disorder characterized by a defect in tricuspid valve function or structure.

MedDRA code (LLT): 10061389 · CTCAE v6.0 (NCI), original English text.

Ventricular arrhythmia

Cardiac disorders
  1. G1Asymptomatic, intervention not indicated
  2. G2Non-urgent medical intervention indicated
  3. G3Urgent intervention indicated
  4. G4Life-threatening consequences; hemodynamic compromise
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia that originates in the ventricles.

MedDRA code (LLT): 10047281 · CTCAE v6.0 (NCI), original English text.

Ventricular fibrillation

Cardiac disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Not applicable
  4. G4Life-threatening consequences; hemodynamic compromise
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia without discernible QRS complexes due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricles.

MedDRA code (LLT): 10047290 · CTCAE v6.0 (NCI), original English text.

Ventricular tachycardia

Cardiac disorders
  1. G1Not applicable
  2. G2Non-urgent medical intervention indicated
  3. G3Symptomatic, urgent intervention indicated
  4. G4Life-threatening consequences; hemodynamic compromise
  5. G5Death
Definition and note

DefinitionA disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates distal to the bundle of His.

MedDRA code (LLT): 10047302 · CTCAE v6.0 (NCI), original English text.

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