Adverse Drug Reactions (Postmaketing)

The incidence of adverse events observed in lenvatinib monotherapy datasets for reactions identified from postmarketing use of lenvatinib are provided in Table 10.

Table 10: Incidence of Adverse Events Reported for Lenvatinib in Monotherapy Datasets for Reactions Identified from Postmarketing Use of Lenvatinib
MedDRA Preferred Terms
/ CTCAE
Lenvatinib DTC   Monotherapy N=458 Lenvatinib RCC   Monotherapy N=52 Lenvatinib HCC   Monotherapy N=496 All Lenvatinib Monotherapy   (1)  N=1823
Any Grade Grade ≥3 Any Grade Grade ≥3 Any Grade Grade ≥3 Any Grade Grade ≥3
Cholecystitis / cholecystitis acute 1.5 1.1 3.8 3.8 0.6 0.4 1.6 1.1
Pancreatitis / pancreatitis acute 0.7 0.7 0 0 0.2 0.2 0.7 0.5
Lipase increased / Hyperlipasemia 3.7 2.6 11.5 7.7 3.6 2.6 3.4 2.1
Amylase increased / Hyperamylasemia 2.4 1.5 3.8 3.8 1 0.4 1.7 0.9
Aortic Dissection 0 0 0 0 0.2 0.2 0.1 0.1
Impaired healing 1.3 0.2 0 0 0.2 0.2 0.8 0.2
Pneumothorax 1.3 0.7 0 0 0.4 0.2 0.9 0.4
Nephrotic syndrome 0.2 0 0 0 0 0 0.2 0
Osteonecrosis of the jaw 0.2 0 0 0 0 0 0.2 0
1 Includes studies of lenvatinib as a monotherapy in subjects with other types of cancer.