Table 2.

Most frequently reported adverse events during lead-in stage regardless of causality (N = 45)

Adverse eventb	All grades		Grade ≥3a
	n	%	n	%
Fatigue	32	71	5	11
Nausea	29	64	1	2
Diarrhea	25	56	2	4
PPE	20	44	6	13
Decreased appetite	20	44	1	2
Vomiting	17	38	1	2
Constipation	13	29	2	4
Hypertension	11	24	3	7
Decreased weight	11	24	2	4
Dysgeusia	11	24	–	–
Dysphonia	11	24	–	–
Abdominal pain	10	22	3	7
Asthenia	10	22	3	7
Headache	10	22	–	–
Dyspnea	9	20	3	7
Dizziness	8	18	–	–
Hypothyroidism	8	18	–	–
Mucosal inflammation	8	18	–	–
Back pain	7	16	2	4
Leukopenia	7	16	1	2
Stomatitis	7	16	1	2
Pain in extremities	7	16	–	–
Pain	6	13	2	4
Alopecia	6	13	–	–
Dyspepsia	6	13	–	–
Rash	6	13	–	–
Urinary tract infection	6	13	–	–
Increased AST	5	11	3	7
Thrombocytopenia	5	11	1	2
Dry mouth	5	11	–	–
Hair color changes	5	11	–	–
Neutropenia	5	11	–	–
Oral pain	5	11	–	–

AST aspartate aminotransferase, PPE palmar-plantar erythrodysesthesia

^aOne related grade 5 event was reported: respiratory compromise

^bMedDRA v. 14.1 Preferred Terms (converted to US spelling), CTCAE v. 3.0 grading