Supplement Table 6. Overview of treatment emergent adverse events (safety population).

	Tolvaptan (N = 46)		Placebo (N = 45)		p value
	No. of events	Subjects (%)	No. of events	Subjects (%)
Treatment emergent adverse event (TEAE)*	61	30 (65.2%)	35	20 (44.4%)	0.0590
Serious TEAE	12	8 (17.4%)	10	8 (17.8%)	1.0000
Mild TEAE	35	22 (47.8%)	18	12 (26.7%)	0.0511
Moderate TEAE	17	12 (26.1%)	8	8 (17.8%)	0.4489
Severe TEAE	9	5 (10.9%)	9	6 (13.3%)	0.7582
TEAE related to study drug	12	8 (17.4%)	6	4 (8.9%)	0.3538
TEAE leading to discontinuation	2	2 (4.3%)	0	0 (0.0%)	0.4945
TEAE resulted to death	0	0 (0.0%)	3	2 (4.4%)	0.2418

* Definition of TEAE (treatment emergent adverse event): TEAE is a new AE experienced by a study subject that occurs after initiation of investigational medicinal product administration; an event or pre-existing medical problem that has changed adversely in nature or severity from baseline in subject while receiving investigational medicinal products.