Table 5.

TEAEs and ADRs

	TEAEs				ADRs
	KRP‐116D (n = 49)		Placebo (n = 47)		KRP‐116D (n = 49)		Placebo (n = 47)
	n (%)	Events	n (%)	Events	n (%)	Events	n (%)	Events
Any AEs	34 (69.4)	142	28 (59.6)	61	29 (59.2)	105	13 (27.7)	25
Any serious AEs	2 (4.1)	–	1 (2.1)	–	0 (0.0)	–	0 (0.0)	–
Any AEs leading to drug withdrawal	1 (2.0)	–	2 (4.3)	–	0 (0.0)	–	1 (2.1)	–
Most common AEs (preferred term incidence in ≥3 patients in any group)
Viral upper respiratory tract infection	6 (12.2)	7	8 (17.0)	9	0 (0.0)	0	0 (0.0)	0
Contusion	3 (6.1)	3	1 (2.1)	1	0 (0.0)	0	0 (0.0)	0
Bladder discomfort	4 (8.2)	6	1 (2.1)	1	4 (8.2)	6	1 (2.1)	1
Bladder irritation	5 (10.2)	8	1 (2.1)	1	5 (10.2)	8	1 (2.1)	1
Bladder pain	15 (30.6)	47	10 (21.3)	15	15 (30.6)	47	9 (19.1)	13
Pollakiuria	4 (8.2)	9	1 (2.1)	1	4 (8.2)	9	1 (2.1)	1
Urethral pain	7 (14.3)	22	2 (4.3)	5	6 (12.2)	21	2 (4.3)	5
AEs at the time of administration
Total	30 (61.2)	100	15 (31.9)	26	29 (59.2)	99	13 (27.7)	23
Postprocedural hematuria	0 (0.0)	0	1 (2.1)	1	0 (0.0)	0	0 (0.0)	0
Groin pain	1 (2.0)	1	0 (0.0)	0	1 (2.0)	1	0 (0.0)	0
Bladder discomfort	4 (8.2)	6	1 (2.1)	1	4 (8.2)	6	1 (2.1)	1
Bladder irritation	5 (10.2)	8	1 (2.1)	1	5 (10.2)	8	1 (2.1)	1
Bladder pain	15 (30.6)	47	10 (21.3)	15	15 (30.6)	47	9 (19.1)	13
Dysuria	2 (4.1)	3	0 (0.0)	0	2 (4.1)	3	0 (0.0)	0
Hematuria	0 (0.0)	0	2 (4.3)	2	0 (0.0)	0	2 (4.3)	2
Pollakiuria	4 (8.2)	9	1 (2.1)	1	4 (8.2)	9	1 (2.1)	1
Urethral pain	7 (14.3)	22	2 (4.3)	5	6 (12.2)	21	2 (4.3)	5
Bladder dysfunction	1 (2.0)	4	0 (0.0)	0	1 (2.0)	4	0 (0.0)	0
Severity of AEs
Mild	33 (67.3)	115	22 (46.8)	43	26 (53.1)	86	12 (25.5)	22
Moderate	9 (18.4)	25	11 (23.4)	17	8 (16.3)	19	2 (4.3)	3
Severe	2 (4.1)	2	1 (2.1)	1	0 (0.0)	0	0 (0.0)	0

Analysis set: safety analysis set.