Table 3.

Adverse events [all grades (occurring in ≥10% subjects), suspected to be related to study treatment] by treatment group

All patients, n (%)Part I, n (%)Part II, n (%)
N = 59N = 29N = 30
Preferred termAll gradesGrade ≥3All gradesGrade ≥3All gradesGrade ≥3
Patients with ≥1 AE59 (100)45 (76)29 (100)22 (76)30 (100)23 (77)
Gastrointestinal
 Diarrhea38 (64)7 (12)20 (69)1 (3)18 (60)6 (20)
 Nausea38 (64)4 (7)22 (76)3 (10)16 (53)1 (3)
 Vomiting30 (51)5 (8)18 (62)2 (7)12 (40)3 (10)
 Gastroesophageal reflux disease18 (31)014 (48)04 (13)0
 Constipation11 (19)04 (14)07 (23)0
 Stomatitis10 (17)07 (24)03 (10)0
 Abdominal pain8 (14)1 (2)6 (21)02 (7)1 (3)
 Dyspepsia8 (14)02 (7)06 (20)0
 Mouth ulceration6 (10)0006 (20)0
Skin and subcutaneous tissue
 Alopecia31 (53)1 (2)16 (55)015 (50)1 (3)
 Rash16 (27)5 (8)11 (38)2 (7)5 (17)3 (10)
 Rash maculopapular15 (25)7 (12)3 (10)2 (7)12 (40)5 (17)
 Pruritus13 (22)04 (14)09 (30)0
General
 Fatigue34 (58)5 (8)16 (55)1 (3)18 (60)4 (13)
 Mucosal inflammation7 (12)05 (17)02 (7)0
Nervous system
 Peripheral neuropathy11 (19)05 (17)06 (20)0
 Peripheral sensory neuropathy10 (17)1 (2)8 (28)02 (7)1 (3)
 Headache6 (10)05 (17)01 (3)0
 Dysgeusia6 (10)02 (7)04 (13)0
Metabolism and nutrition
 Decreased appetite23 (39)1 (2)13 (45)1 (3)10 (33)0
 Hypomagnesemia15 (25)7 (12)8 (28)5 (17)7 (23)2 (7)
Hematologic
 Neutropenia19 (32)13 (22)15 (52)12 (41)4 (13)1 (3)
 Anemia14 (24)5 (8)4 (14)2 (7)10 (33)3 (10)
 Thrombocytopenia13 (22)4 (7)6 (21)2 (7)7 (23)2 (7)
Musculoskeletal and connective tissue
 Arthralgia14 (24)08 (28)06 (20)0
 Myalgia11 (19)08 (28)03 (10)0
Respiratory
 Dyspnea6 (10)1 (2)5 (17)01 (3)1 (3)
Allergy
 Drug hypersensitivity6 (10)04 (17)02 (7)0
 Hypersensitivity6 (10)1 (2)2 (7)1 (3)4 (13)0