Table 2.

All Grade 3–5 Adverse Events and All Grade 1–2 Adverse Events Reported by at Least Three Patients

Adverse Event	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
Abdominal pain	2 (5.7%)	0	1 (2.9%)	0	0
Agitation	1 (2.9%)	0	1 (2.9%)	0	0
Anorexia	8 (22.9%)	8 (22.9%)	0	0	0
Anxiety	0	1 (2.9%)	1 (2.9%)	0	0
Colonic fistula	0	0	1 (2.9%)	0	0
Colonic perforation	0	0	0	1 (2.9%)	1 (2.9%)
Depression	2 (5.7%)	0	1 (2.9%)	0	0
Diarrhea	13 (37.1%)	11 (31.4%)	3 (8.6%)	0	0
Dyspnea	0	0	2 (5.7%)	0	0
Fatigue	7 (20.0%)	10 (28.6%)	5 (14.3%)	0	0
Hand and foot syndrome/reaction	0	1 (2.9%)	2 (5.7%)	0	0
Hypertension	7 (20.0%)	10 (28.6%)	1 (2.9%)	0	0
Infectious colitis (grade 0–2 ANC)	0	0	1 (2.9%)	0	0
Joint pain	1 (2.9%)	1 (2.9%)	1 (2.9%)	0	0
Myalgia	3 (8.6%)	0	0	0	0
Nausea	12 (34.3%)	6 (17.1%)	0	0	0
Neutrophil count decreased	4 (11.4%)	1 (2.9%)	1 (2.9%)	0	0
Peripheral sensory neuropathy	6 (17.1%)	0	0	0	0
Pneumonitis	0	0	1 (2.9%)	0	0
Skin hypopigmentation	18 (51.4%)	4 (11.4%)	0	0	0
Skin ulceration	0	0	0	1 (2.9%)	0
Reproductive tract disorder	0	0	1 (2.9%)	0	0
Taste alteration	5 (14.3%)	0	0	0	0
Vomiting	7 (20.0%)	1 (2.9%)	1 (2.9%)	0	0
Weight loss	0	4 (11.4%)	1 (2.9%)	0	0
Alanine aminotransferase increased	3 (8.6%)	1 (2.9%)	0	0	0
Aspartate aminotransferase increased	10 (28.6%)	3 (8.6%)	1 (2.9%)	0	0
Bilirubin increased	2 (5.7%)	1 (2.9%)	0	0	0
Hemoglobin decreased	7 (20.0%)	2 (5.7%)	0	0	0
Leukocyte count decreased	9 (25.7%)	4 (11.4%)	1 (2.9%)	0	0
Lipase increased	0	0	0	1 (2.9%)	0
Lymphocyte count decreased	0	1 (2.9%)	1 (2.9%)	0	0
Platelet count decreased	9 (25.7%)	1 (2.9%)	0	0	0
Protein urine positive	9 (25.7%)	4 (11.4%)	0	0	0
Serum cholesterol increased	3 (8.6%)	0	0	0	0

Abbreviation: ANC, absolute neutrophil count.