Table 2.

TRAEs (in ≥30% of patients), select TRAEs, and TRAEs leading to discontinuation in ≥2 patients

TRAE, preferred term, n (%)a	Treatment arm
	N + S (N = 33)		N + P (N = 20)
	All grades	Grade 3 or 4	All grades	Grade 3 or 4
Total patients with an event	33 (100.0)	27 (81.8)	20 (100.0)	14 (70.0)
Fatigue	28 (84.8)	3 (9.1)	12 (60.0)	3 (15.0)
Diarrhea	21 (63.6)	3 (9.1)	12 (60.0)	4 (20.0)
Dysgeusia	21 (63.6)	0	10 (50.0)	0
Nausea	19 (57.6)	1 (3.0)	15 (75.0)	0
Hypertension	16 (48.5)	6 (18.2)	5 (25.0)	2 (10.0)
Decreased appetite	16 (48.5)	1 (3.0)	8 (40.0)	0
Increased ALT	13 (39.4)	6 (18.2)	5 (25.0)	4 (20.0)
Palmar-plantar erythrodysesthesia syndrome	13 (39.4)	0	0	0
Increased AST	12 (36.4)	3 (9.1)	6 (30.0)	4 (20.0)
Blood creatinine increased	11 (33.3)	2 (6.1)	1 (5.0)	0
Hypothyroidism	11 (33.3)	0	4 (20.0)	1 (5.0)
Dyspepsia	11 (33.3)	0	4 (20.0)	0
Dry skin	11 (33.3)	0	2 (10.0)	0
Mucosal inflammation	10 (30.3)	0	5 (25.0)	0
Dry mouth	10 (30.3)	0	1 (5.0)	0
Arthralgia	8 (24.2)	0	7 (35.0)	1 (5.0)
Pruritus	8 (24.2)	0	7 (35.0)	0
Vomiting	7 (21.2)	1 (3.0)	6 (30.0)	0
Select TRAE, organ class, n (%)b
Skin	26 (78.8)	2 (6.1)	11 (55.0)	0
Endocrine	12 (36.4)	0	5 (25.0)	2 (10.0)
Gastrointestinal	21 (63.6)	3 (9.1)	12 (60.0)	4 (20.0)
Hepatic	15 (45.5)	8 (24.2)	7 (35.0)	4 (20.0)
Renal	13 (39.4)	4 (12.1)	1 (5.0)	0
Pulmonary	1 (3.0)	1 (3.0)	1 (5.0)	0
TRAE leading to discontinuation, preferred term, n (%)a
Total patients with an event	13 (39.4)	11 (33.3)	5 (25.0)	4 (20.0)
Increased ALT	3 (9.1)	2 (6.1)	3 (15.0)	3 (15.0)
Acute kidney injury	3 (9.1)	1 (3.0)	0	0
Increased AST	1 (3.0)	1 (3.0)	3 (15.0)	3 (15.0)

^aIncludes events reported between the first dose and 100 days after the last dose of study therapy

^bIncludes events reported between the first dose and 30 days after the last dose of study therapy