Table 4. Safety Outcomes.

	No. (%)		P Value
	Levosimendan (n = 167)	Placebo (n = 168)a
Patients with any adverse event	160 (96)	155 (92)	.17
Patients with any serious adverse eventb	149 (89)	145 (86)	.40
Hypotension after treatment initiation before CPB	95 (57)	80 (48)	.11
Patients receiving fluids to correct hypotension	49 (50)	39 (47)	.69
Colloid	9 (18)	5 (13)	.31
Crystalloid	35 (71)	33 (85)
Crystalloid and colloid	5 (10)	1 (3)
Total fluid volume administered, median (IQR) [range], mL	500 (325-538) [250-2500]	500 (500-750) [250-2500]	.13
Patients receiving vasoconstrictors to correct hypotension	81 (49)	66 (39)	.11
Ephedrine	53 (32)	48 (29)	.58
Phenylephrine	34 (20)	24 (14)	.16
Norepinephrine	34 (20)	25 (15)	.21
Epinephrine	8 (5)	1 (1)	.04
Highest troponin value between hours 24 and 48 after surgery, median (IQR) [range], µg/Lc	2.9 (0.7-6.5) [0.1-657]	3.0 (0.8-9.3) [0.1-399]	.40
Arrhythmia or conduction disturbance during hospital stay	104 (62)	94 (56)	.24
Postoperative atrial fibrillation	83 (50)	68 (40)	.09
Ventricular tachycardia	20 (12)	18 (11)	.72
Ventricular fibrillation	24 (14)	27 (16)	.67
Third-degree atrioventricular block	7 (4)	15 (9)	.08
No. of times patients required electrical cardioversion in the OR
1	18 (56)	21 (64)	.20
2	6 (19)	9 (27)
≥3	8 (25)	3 (9)
Reasons for study drug interruption before end of treatment	14 (8)	5 (3)	.03
Refractory hypotension	5 (3)	1 (1)	.12
Death during study drug infusion	2 (1)	0	.25

Abbreviations: CPB, cardiopulmonary bypass; OR, operating room.

^aTwo patients in the placebo group refused participation after randomization.

^bThe complete list of serious adverse events is provided as a supplement (eTable 3 in Supplement 2).

^cTroponin value measured between hours 24 and 48 after the end of the surgery.