Table 2.
AEs in both groups
| Before PDa |
AEs occurred during beyond PDa treatment with LEN |
|||
|---|---|---|---|---|
| group A (n = 26) (grade 0:1:2:3) | group B (n = 73) (grade 0:1:2:3) | p value | group B (grade 1:2:3) | |
| HFSR | 22:2:1:1 | 44:13:16:0 | 0.019 | 1:2:0 |
| Appetite loss | 16:2:7:1 | 46:14:10:3 | 0.286 | 6:7:0 |
| General fatigue | 15:6:4:1 | 52:10:11:0 | 0.227 | 3:1:0 |
| Hypertension | 22:1:2:1 | 54:5:12:2 | 0.679 | 1:0:0 |
| Urine protein | 20:3:1:2 | 55:6:7:5 | 0.838 | 0:4:2 |
| Abnormality of thyroid function | 17:4:4:1 | 49:9:14:1 | 0.763 | 1:1:1 |
| Diarrhea | 22:3:2:1 | 55:11:6:1 | 0.639 | 2:3:0 |
| Elevation of the levels of NH3 | 23:0:0:3 | 67:1:1:4 | 0.665 | 1:0:1 |
| Hoarseness | 23:3:0:0 | 58:13:2:0 | 0.754 | 3:0:0 |
| Decreasing the levels of platelet count | 25:0:0:1 | 70:0:1:2 | 1.000 | None |
| Elevation of the levels of transaminase | 25:1:0:0 | 71:1:0:1 | 0.603 | 0:3:0 |
| Other AEs of grade 3 | None | Body weight loss (n = 1) | 1.00 | Fever up (n = 3) |
| Fever up (n = 1) | ||||
| Neutropenia (n = 1) | ||||
LEN, lenvatinib; PD, progression of disease; AE, adverse event; HFSR, hand-foot skin reaction; na, not applicable.
a
Evaluated by RECIST 1.1.