Table 5.
The types and grades of AEs in both groups.
| Combination group (n = 9) | Monotherapy group (n = 13) | p-value | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Total | Grade 1 | Grade 2 | Grade 3 | Total | ||
| Hypertension | 0 | 4 (44.4%) | 0 | 4 (44.4%) | 0 | 8 (61.5%) | 1 (7.7%) | 9 (69.2%) | 0.245 |
| Appetite loss | 3 (33.3%) | 4 (44.4%) | 0 | 7 (77.8%) | 2 (15.4%) | 4 (30.8%) | 0 | 6 (46.2%) | 0.138 |
| Fatigue | 4 (44.4%) | 0 | 1 (11.1%) | 5 (55.6%) | 2 (15.4%) | 3 (23.1%) | 1 (7.7%) | 6 (46.2%) | 0.665 |
| Proteinuria | 0 | 1 (11.1%) | 0 | 1 (11.1%) | 0 | 2 (15.4%) | 0 | 2 (15.4%) | 0.774 |
| Hypothyroidism | 0 | 1 (11.1%) | 0 | 1 (11.1%) | 0 | 1 (7.7%) | 0 | 1 (7.7%) | 0.784 |
| Diarrhea | 1 (11.1%) | 0 | 0 | 1 (11.1%) | 0 | 0 | 0 | 0 | / |
| Hand or foot skin reaction | 2 (22.2%) | 0 | 0 | 2 (22.2%) | 1 (7.7%) | 1 (7.7%) | 0 | 2 (15.4%) | 0.683 |
| Rash | 0 | 0 | 1 (7.7%) | 0 | 1 (7.7%) | / | |||
| Temperature increase | 4 (44.4%) | 0 | 0 | 4 (44.4%) | 0 | / | |||
| AST elevation | 1 (11.1%) | 4 (44.4%) | 3 (33.3%) | 8 (88.9%) | 7 (53.8%) | 0 | 0 | 7 (53.8%) | 0.083 |
| ALT elevation | 6 (66.7%) | 1 (11.1%) | 1 (11.1%) | 8 (88.9%) | 3 (23.1%) | 1 (7.7%) | 0 | 4 (30.8%) | 0.007 |
| mALBI grade elevation1 | / | 4 (44.4%) | / | 6 (46.2%) | 0.937 | ||||
1Here, the elevation of the mALBI grade was the difference between mALBI at the end of the treatment as a whole and mALBI at the beginning of the initial lenvatinib treatment.
AEs, adverse events; AST, aspartate transaminase; ALT, alanine transaminase; mALBI, modified albumin–bilirubin. Data are presented as n and percentages (%).