Table 3.

Incidence and severity of most frequently-occurring ADRs.

Major ADRs	ADRs n (%)	Serious ADRs n (%)
Gastrointestinal disorders
Nausea	748 (20.3)	1 (0.0)
Vomiting	362 (9.8)	5 (0.1)
Diarrhea	71 (1.9)	2 (0.0)
Blood system disorders
Leukopenia	637 (17.3)	8 (0.2)
Neutropenia	445 (12.1)	9 (0.2)
Anemia	258 (7.0)	2 (0.0)
Thrombocytopenia	207 (5.6)	6 (0.2)
Peripheral nervous system disorders
Paresthesia or disesthesia (hands and feet)	211 (5.7)	0 (0.0)
Abnormal hepatic function	186 (5.1)	6 (0.2)
Hypersensitivity reactions	118 (3.2)	18 (0.5)