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 | 0.1 | 0 |
| 1 Includes studies of lenvatinib as a monotherapy in subjects with other types of cancer. | ||||||||
