Table 3.

Lenvatinib Phase II and III trials toxicities profile

	Phase II and III studies
	SELECT trial*47	Phase II*45	Phase II*46
n	392	58	59
Cohort	Radioiodine-refractory thyroid cancer of follicular origin	Radioiodine-refractory thyroid cancer of follicular origin	Refractory medullary thyroid
Common clinical AEs**	Hypertension, diarrhea, fatigue, decreased appetite, nausea, vomiting, weight loss	Weight loss, hypertension, diarrhea, fatigue, dehydration, arthralgia	Diarrhea, hypertension, decreased appetite, fatigue
Grade ≥3	75%	72%	61%
Discontinuation of medication due to AEs	14%	26%	24%
Dose reduction due to AEs	67%	66%	59%
Dose delay due to AEs	82%	74%	75%
Number of deaths on study	6	2	3
Cause of death	Three unspecified, one pulmonary embolism, one hemorrhagic stroke, one health deterioration	One cardiac arrest, one arterial hemorrhage	Two respiratory failures (one not specified), one paraneoplastic syndrome

Notes:

^*Lenvatinib was administered at 24 mg po daily in 28-day treatment cycles.

^**Grade ≥3 proteinuria was present in 10% of patients in two of the trials described in the table and AEs are presented in descending order of frequency.

Abbreviation: AEs, adverse events.