Table 5.

Phase 2 axitinib trials – adverse events.

Author(s)	Rini et al. (2009)		Rixe et al. (2007)		Tomita et al. (2011)
Previous therapy	Sorafenib refractory ± other* (N = 62)		Cytokine refractory (N = 52)		Cytokine refractory (N = 64)
Axitinib dose/schedule	5.0 mg BID, dose escalation		5.0 mg BID, dose escalation		5.0 mg BID, dose escalation
Adverse event	All Gr (%)	≥ Gr 3 (%)	All Gr (%)	≥ Gr 3 (%)	All Gr (%)	≥ Gr 3 (%)
Diarrhea	60	10	61	15	64	5
Hypertension	58	15	45	16	84	70
Fatigue	52	8	77	16	48	5
Nausea	44	0	44	7	25	0
Dysphonia	NS	Ns	37	0	53	0
Hand–foot syndrome	NS	NS	36	16	75	22
Anorexia	35	2	48	0	36	5
Weight loss	27	0	31	5	30	3
Dyspepsia	23	0	NS	NS	NS	NS
Vomiting	21	0	32	5	16	0
Headache	NS	NS	29	0	23	0
Arthralgia	NS	NS	27	3	19	3

BID, twice daily; Gr, grade.

*Previous therapy may also have included bevacizumab, sunitinib, temsirolimus, cytokines, chemotherapy, and/or other.