Table 2

Most common treatment-related adverse events (any grade in ≥25% of patients or grade ≥3 in ≥10% of patients in any arm; treatment related according to investigator assessment)

Adverse event, n (%)Arm A (n=36)Arm B (n=18)Arm C (n=30)
Any gradeGrade 1/2Grade ≥3Any gradeGrade 1/2Grade ≥3Any gradeGrade 1/2Grade ≥3
Any32 (89)10 (28)22 (61)12 (67)11 (61)1 (6)29 (97)10 (34)19 (63)
Diarrhea18 (50)15 (42)3 (8)1 (6)1 (6)09 (30)7 (23)2 (7)
Aspartate aminotransferase increased17 (47)15 (42)2 (6)00016 (53)14 (47)2 (7)
Alanine aminotransferase increased15 (42)12 (33)3 (8)00014 (47)12 (40)2 (7)
Fatigue14 (39)13 (36)1 (3)6 (33)6 (33)016 (53)14 (47)2 (7)
Hypertension11 (31)5 (14)6 (17)00010 (33)7 (23)3 (10)
Anorexia11 (31)11 (31)01 (6)1 (6)06 (20)6 (20)0
Nausea11 (31)10 (28)1 (3)2 (11)2 (11)011 (37)10 (33)1 (3)
Weight loss11 (31)11 (31)01 (6)1 (6)06 (20)6 (20)0
Mucositis oral11 (31)9 (25)2 (6)1 (6)1 (6)03 (10)3 (10)0
Platelet count decreased10 (28)9 (25)1 (3)0006 (20)6 (20)0
Hypothyroidism8 (22)8 (22)01 (6)1 (6)09 (30)9 (30)0
Palmar-plantar erythrodysesthesia syndrome8 (22)6 (17)2 (6)0008 (27)8 (27)0
Anemia6 (17)4 (11)2 (6)1 (6)1 (6)013 (43)11 (37)2 (7)
Thyroid-stimulating hormone increased5 (14)5 (14)01 (6)1 (6)08 (27)8 (27)0
Lymphocyte count decreased4 (11)3 (8)1 (3)1 (6)01 (6)7 (23)1 (3)6 (20)