Table 4.
Most common TEAEs a in ⩾20% of patients treated with lenvatinib.
| Preferred term, n (%) | CP-B, n = 60 | CP-A, n = 413 | ||
|---|---|---|---|---|
| Any grade | Grade ⩾3 | Any grade | Grade ⩾3 | |
| Ascites | 20 (33.3) | 8 (13.3) | 47 (11.4) | 9 (2.2) |
| Blood bilirubin increased | 21 (35.0) | 11 (18.3) | 50 (12.1) | 20 (4.8) |
| Constipation | 13 (21.7) | 0 | 61 (14.8) | 3 (0.7) |
| Decreased appetite | 27 (45.0) | 7 (11.7) | 133 (32.2) | 15 (3.6) |
| Diarrhea | 22 (36.7) | 4 (6.7) | 162 (39.2) | 16 (3.9) |
| Dysphonia | 16 (26.7) | 0 | 96 (23.2) | 1 (0.2) |
| Fatigue | 18 (30.0) | 6 (10.0) | 123 (29.8) | 12 (2.9) |
| Hepatic encephalopathy | 17 (28.3) | 10 (16.7) | 20 (4.8) | 13 (3.1) |
| Hypertension | 27 (45.0) | 14 (23.3) | 173 (41.9) | 97 (23.5) |
| Hypoalbuminemia | 12 (20.0) | 1 (1.7) | 31 (7.5) | 2 (0.5) |
| Hypothyroidism | 15 (25.0) | 0 | 63 (15.3) | 0 |
| Nausea | 14 (23.3) | 2 (3.3) | 78 (18.9) | 2 (0.5) |
| Palmar-plantar erythrodysesthesia syndrome | 12 (20.0) | 0 | 116 (28.1) | 14 (3.4) |
| Platelet count decreased | 13 (21.7) | 6 (10.0) | 74 (17.9) | 20 (4.8) |
| Proteinuria | 15 (25.0) | 4 (6.7) | 102 (24.7) | 23 (5.6) |
| Vomiting | 13 (21.7) | 3 (5.0) | 63 (15.3) | 3 (0.7) |
| Weight decreased | 18 (30.0) | 4 (6.7) | 129 (31.2) | 32 (7.7) |
a
AEs were graded using Common Terminology Criteria for Adverse Events version 4.0.
CP, Child-Pugh; TEAEs, treatment-emergent adverse events.