TABLE 3

Summary of safety and tolerability

Study 1Study 2
GefapixantPlaceboGefapixantPlacebo
50 mg100 mg150 mg200 mgTotal7.5 mg15 mg30 mg50 mgTotal
Subjects n282726262828303030303029
Any adverse event17 (60.7)22 (81.5)23 (88.5)24 (92.3)26 (92.9)14 (50.0)8 (26.7)10 (33.3)20 (66.7)23 (76.7)24 (80.0)9 (31.0)
Subjects with drug-related adverse events17 (60.7)22 (81.5)23(88.5)24 (92.3)26 (92.9)4 (14.3)4 (13.3)5 (16.7)16 (53.3)19 (63.3)19 (63.3)2 (6.9)
Subjects with renal/urological adverse events2 (7.1)2 (7.4)1 (3.8)1 (3.8)3 (10.7)2 (7.1)01 (3.3)1 (3.3)3 (10.0)3 (10.0)1 (3.4)
Subjects with serious adverse events01 (3.7)001 (3.6)1 (3.6)0001 (3.3)1 (3.3)0
Discontinuation due to adverse events1 (3.6)1 (3.7)002 (7.1)1 (3.6)0001 (3.3)1 (3.3)0
Most common adverse events (>2 subjects in a treatment group)
 Dysgeusia13 (46.4)19 (70.4)21 (80.8)21 (80.8)22 (78.6)1 (3.6)2 (6.7)2 (6.7)14 (46.7)16 (53.3)16 (53.3)0
 Hypoaesthesia oral1 (3.6)3 (11.1)2 (7.7)3 (11.5)4 (14.3)0
 Upper respiratory tract infection0004 (13.3)4 (13.3)0
 Paraesthesia oral2 (7.1)3 (11.1)3 (11.5)4 (15.4)4 (14.3)0002 (6.7)2 (6.7)3 (10.0)0
 Hypogeusia2 (7.1)4 (14.8)4 (15.4)4 (15.4)4 (14.3)0
 Rhinitis2 (6.7)2 (6.7)2 (6.7)02 (6.7)0
 Flank pain1 (3.6)1 (3.7)02 (7.7)3 (10.7)0
 Ageusia2 (7.1)1 (3.7)1 (3.8)1 (3.8)3 (10.7)00002 (6.7)2 (6.7)0
 Nasal dryness2 (6.7)2 (6.7)2 (6.7)2 (6.7)2 (6.7)0
 Urine output decreased2 (7.1)2 (7.4)2 (7.7)1 (3.8)2 (7.1)0
 Cough01 (3.7)2 (7.7)1 (3.8)2 (7.1)0
 Dry mouth1 (3.6)1 (3.7)1 (3.8)1 (3.8)1 (3.6)0001 (3.3)1 (3.3)1 (3.3)2 (6.9)

Data are presented as n (%), unless otherwise stated.