Table 1.

Summary of adverse events observed in the main clinical studies leading to Vandetanib approval.

	Phase I, Holden et al 50–600 mg	Phase I, Tamura et al 100–400 mg	Phase II, Wells et al 300 mg	Phase III, Wells et al 300 mg	Phase III, Wells et al Placebo
Diarrhea (%)	38	61	70	56	26
Rash (%)	34	72	67	45	11
Nausea (%)	19	22	63	33	16
Hypertension (%)	18	39	33	32	5
Fatigue (%)	18	44	63	24	23
ECG QTc prolongation (%)	9	67	20	14	1
Adverse events leading to death (n)	0	0	0	5	0