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Most Frequent

Treatment-Related

Adverse Events

Adverse Event

Lenvatinib (n=261)

Placebo (n=131)

Any Grade (%) Grade ≥ 3 (%)

Any Grade (%) Grade ≥ 3 (%)

Hypertension

67.8

41.8

9.2

2.3

Diarrhea

59.4

8

8.4

0

Decreased appetite

50.2

5.4

11.5

0

Decreased weight

46.4

9.6

9.2

0

Nausea

41.0

2.3

13.7

0.8

Fatigue

39.5

4.6

19.1

0.8

Stomatitis

35.6

4.2

3.8

0

Palmar-plantar erthrodysesthesia

syndrome

31.8

3.4

0.8

0

Proteinuria

31.0

10

1.5

0

Vomiting

28.4

1.9

6.1

0

Headache

27.6

2.7

6.1

0

Schlumberger M, et al. N Engl J Med 2015;372:621-30. DOI: 10.1056/NEJMoa1406470