Table 4

Adverse Events

Patient IncidencePooled Placebo (n = 303)Pooled OM
(n = 303)
Cohort 1 OM
(n = 103)
Cohort 2 OM
(n = 99)
Cohort 3 OM
(n = 101)
All AEs191 (63.0)177 (58.4)73 (70.9)49 (49.5)55 (54.5)
3 most common AEs
 Cardiac failure53 (17.5)46 (15.2)17 (16.5)14 (14.1)15 (14.9)
 Hypokalemia18 (5.9)20 (6.6)7 (6.8)7 (7.1)6 (5.9)
 Hypotension14 (4.6)24 (7.9)14 (13.6)5 (5.1)5 (5.0)
All serious AEs70 (23.1)66 (21.8)24 (23.3)24 (24.2)18 (17.8)
3 most common serious AEs
 Cardiac failure29 (9.6)26 (8.6)8 (7.8)11 (11.1)7 (6.9)
 Acute renal failure4 (1.3)6 (2.0)2 (1.9)2 (2.0)2 (2.0)
 Hypotension0 (0.0)3 (1.0)3 (2.9)0 (0.0)0 (0.0)
Deaths through 30 days10 (3.3)8 (2.6)1 (1.0)4 (4.0)3 (3.0)
 HF9 (3.0)4 (1.3)0 (0.0)2 (2.0)2 (2.0)
 Sudden cardiac death1 (0.3)2 (0.6)1 (1.0)1 (1.0)0 (0.0)
 MI0 (0.0)1 (0.3)0 (0.0)0 (0.0)1 (1.0)
 Other cardiovascular0 (0.0)1 (1.0)0 (0.0)0 (0.0)1 (1.0)
AEs leading to discontinuation of investigational product15 (5.0)15 (5.0)7 (6.8)4 (4.0)4 (4.0)
Number of subjects reporting AEs of ischemic heart disease, MI, increased troponins5 (1.7)9 (3.0)2 (1.9)2 (2.0)5 (5.0)
Number of subjects reporting AEs of SVTs or VTs34 (11.2)26 (8.6)13 (12.6)5 (5.1)8 (7.9)
 SVTs20 (6.6)11 (3.6)6 (5.8)0 (0.0)5 (5.0)
 AF or atrial flutter16 (5.3)7 (2.3)3 (2.9)0 (0.0)4 (4.0)
 VTs18 (5.9)16 (5.2)8 (7.8)5 (5.1)3 (3.0)

Values are n (%).

AE = adverse event; SVT = supraventricular tachyarrhythmia; VT = ventricular tachyarrhythmia; other abbreviations as in Table 1.

  • Cardiac failure includes both “Cardiac failure” and “Cardiac failure congestive” preferred terms.