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Table 1 Study definitions and severity grades for pazopanib-related cardiovascular adverse events

From: Assessment of pazopanib-related hypertension, cardiac dysfunction and identification of clinical risk factors for their development

Hypertension
 Grade 1: Pre-hypertension (systolic BP 120–139 mmHg or diastolic BP 80–89 mmHg)
 Grade 2: Stage 1 hypertension (systolic BP 140–159 mmHg or diastolic BP 90–99 mmHg); medical intervention indicated; recurrent or persistent (≥24 h); symptomatic increase by >20 mmHg (diastolic) or to >140/90 mmHg if previously within normal limits; monotherapy indicated
 Grade 3: Stage 2 hypertension (systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg); medical intervention indicated; more than 1 drug or more intensive therapy than previously used indicated
 Grade 4: Life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis); urgent intervention indicated
 Grade 5: Death
Heart Failure
 Grade 1: Asymptomatic with laboratory (e.g., BNP) or cardiac imaging abnormalities
 Grade 2: Symptoms with mild to moderate exertion
 Grade 3: Severe with symptoms at rest or with minimal activity or exertion, intervention indicated
 Grade 4: Life-threatening consequences; urgent intervention indicated (e.g., continuous IV therapy or mechanical hemodynamic support)
 Grade 5: Death
Electrocardiogram QT corrected interval (QTc) prolonged
 Grade 1: QTc 450 – 480 ms
 Grade 2: QTc 481 – 500 ms
 Grade 3: QTc > = 501 ms on at least two separate ECGs
 Grade 4: QTc > = 501 or >60 ms change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia.
Atrial flutter
 Grade 1: Asymptomatic, intervention not indicated
 Grade 2: Non-urgent medical intervention indicated
 Grade 3: Symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker), or ablation
 Grade 4: Life-threatening consequences; urgent intervention indicated
 Grade 5: Death
Peripheral ischemia
 Grade 1: Not defined
 Grade 2: Brief (< 24 h) episode of ischemia managed non-surgically and without permanent deficit
 Grade 3: Recurring or prolonged (> = 24 h) and/or invasive intervention indicated
 Grade 4: Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
 Grade 5: Death
  1. Adapted from the National Cancer Institute’s Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) [29]. Per the CTCAE original document, a semi-colon indicates ‘or’ within the description of the grade. High-grade adverse events discussed in the text refer to any event assigned a grade of 3, 4, or 5
  2. BP blood pressure, BNP brain natriuretic peptide, IV intravenous, QTc correct QT interval, ECG electrocardiogram
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Cardio-Oncology

ISSN: 2057-3804

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