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

TRAE, preferred term, n (%)aTreatment arm
N + S (N = 33)N + P (N = 20)
All gradesGrade 3 or 4All gradesGrade 3 or 4
Total patients with an event33 (100.0)27 (81.8)20 (100.0)14 (70.0)
 Fatigue28 (84.8)3 (9.1)12 (60.0)3 (15.0)
 Diarrhea21 (63.6)3 (9.1)12 (60.0)4 (20.0)
 Dysgeusia21 (63.6)010 (50.0)0
 Nausea19 (57.6)1 (3.0)15 (75.0)0
 Hypertension16 (48.5)6 (18.2)5 (25.0)2 (10.0)
 Decreased appetite16 (48.5)1 (3.0)8 (40.0)0
 Increased ALT13 (39.4)6 (18.2)5 (25.0)4 (20.0)
 Palmar-plantar erythrodysesthesia syndrome13 (39.4)000
 Increased AST12 (36.4)3 (9.1)6 (30.0)4 (20.0)
 Blood creatinine increased11 (33.3)2 (6.1)1 (5.0)0
 Hypothyroidism11 (33.3)04 (20.0)1 (5.0)
 Dyspepsia11 (33.3)04 (20.0)0
 Dry skin11 (33.3)02 (10.0)0
 Mucosal inflammation10 (30.3)05 (25.0)0
 Dry mouth10 (30.3)01 (5.0)0
 Arthralgia8 (24.2)07 (35.0)1 (5.0)
 Pruritus8 (24.2)07 (35.0)0
 Vomiting7 (21.2)1 (3.0)6 (30.0)0
Select TRAE, organ class, n (%)b
 Skin26 (78.8)2 (6.1)11 (55.0)0
 Endocrine12 (36.4)05 (25.0)2 (10.0)
 Gastrointestinal21 (63.6)3 (9.1)12 (60.0)4 (20.0)
 Hepatic15 (45.5)8 (24.2)7 (35.0)4 (20.0)
 Renal13 (39.4)4 (12.1)1 (5.0)0
 Pulmonary1 (3.0)1 (3.0)1 (5.0)0
TRAE leading to discontinuation, preferred term, n (%)a
 Total patients with an event13 (39.4)11 (33.3)5 (25.0)4 (20.0)
  Increased ALT3 (9.1)2 (6.1)3 (15.0)3 (15.0)
  Acute kidney injury3 (9.1)1 (3.0)00
  Increased AST1 (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