Table 3.

Cardiac adverse events (regardless of relationship) reported with plitidepsin treatment.

	All studies (n = 578)	Phase II studies (n = 364)
Group/Subgroup/Terms *	Patients (%)	Patients (%)
Rhythm Abnormalities	31 (5.4%)	25 (6.9%)
Regular Supraventricular Tachycardia	6 (1.0%)	1 (0.3%)
Sinus tachycardia	1 (0.2%)	1 (0.3%)
Supraventricular arrhythmia	1 (0.2%)	0 (0.0%)
Supraventricular tachycardia	1 (0.2%)	0 (0.0%)
Tachycardia	3 (0.5%)	0 (0.0%)
Irregular Supraventricular Tachycardia	15 (2.6%)	14 (3.8%)
Atrial fibrillation	11 (1.9%)	10 (2.7%)
Atrial flutter	5 (0.9%)	5 (1.4%)
Heart rate irregular	1 (0.2%)	1 (0.3%)
Other Rhythm Abnormalities	13 (2.2%)	13 (3.6%)
Arrhythmia	1 (0.2%)	1 (0.3%)
Atrioventricular block	1 (0.2%)	1 (0.3%)
Change in electrocardiogram	1 (0.2%)	1 (0.3%)
Electrocardiogram QT prolonged	5 (0.9%)	5 (1.4%)
Palpitations	6 (1.0%)	6 (1.6%)
Myocardial Injury	17 (3.0%)	14 (3.8%)
Possible Ischemic Related	10 (1.7%)	8 (2.2%)
Acute myocardial infarction	1 (0.2%)	1 (0.3%)
Cardiac troponin I increased	1 (0.2%)	1 (0.3%)
Chest pain	4 (0.7%)	2 (0.5%)
Electrocardiogram ST-T change	1 (0.2%)	1 (0.3%)
Myocardial ischemia	3 (0.5%)	3 (0.8%)
Other Myocardial Injury	7 (1.2%)	6 (1.6%)
Cardiac failure	3 (0.5%)	2 (0.5%)
Cardiomegaly	1 (0.2%)	1 (0.3%)
Cardiomyopathy	2 (0.3%)	2 (0.5%)
Ejection fraction decreased	1 (0.2%)	1 (0.3%)
Miscellaneous Cardiac Adverse Events	6 (1.0%)	3 (0.8%)
Cardiac amyloidosis	1 (0.2%)	1 (0.3%)
Hypertension	1 (0.2%)	0 (0.0%)
Hypotension	2 (0.3%)	2 (0.5%)
Pericardial effusion	3 (0.5%)	1 (0.3%)
Ventricular hypokinesia	1 (0.2%)	1 (0.3%)
Total Adverse Events	46 (8.0%)	37 (10.2%)

^*A patient may have more than one cardiac adverse event (CAE). The median number of plitidepsin-related CAEs was 1 (range 1–2), and the median number of CAEs (regardless of relationship) was 1 (range 1–3). Four patients had ≥2 plitidepsin-related CAEs; 14 patients had ≥2 CAEs (regardless of relationship).