Table 3.
Common treatment-related adverse events (≥20%) occurred in patients with bone metastases.
| All grades | Grade 3 or worse | |||
|---|---|---|---|---|
| Adverse events n(%) | Anlotinib (n=29) |
Placebo (n=18) |
Anlotinib (n=29) |
Placebo (n=18) |
| All | 29 (100.0) | 18 (100.0) | 17 (58.6) | 9 (50.0) |
| Palmar-plantar erythrodysesthesia syndrome | 19 (65.5) | 7 (38.9) | 4 (13.8) | 2 (11.1) |
| Proteinuria | 18 (62.1) | 7 (38.9) | 0 (0.0) | 0 (0.0) |
| Hypertension | 16 (55.2) | 6 (33.3) | 1 (3.5) | 2 (11.1) |
| QT interval prolongation | 15 (51.7) | 2 (11.1) | 0 (0.0) | 0 (0.0) |
| Diarrhea | 13 (44.8) | 8 (44.4) | 2 (6.9) | 0 (0.0) |
| Hypertriglyceridemia | 12 (41.4) | 7 (38.9) | 2 (6.9) | 0 (0.0) |
| Fatigue | 12 (41.4) | 5 (27.8) | 2 (6.9) | 0 (0.0) |
| Hypercholesteremia | 11 (37.9) | 4 (22.2) | 0 (0.0) | 1 (5.6) |
| ALT increase | 11 (37.9) | 1 (5.6) | 1 (3.5) | 0 (0.0) |
| Pharyngalgia | 10 (34.5) | 4 (22.2) | 1 (3.5) | 1 (5.6) |
| Urine erythrocyte positive | 10 (34.5) | 4 (22.2) | 0 (0.0) | 0 (0.0) |
| GGT elevation | 10 (34.5) | 1 (5.6) | 1 (3.5) | 0 (0.0) |
| LDL increase | 10 (34.5) | 1 (5.6) | 0 (0.0) | 0 (0.0) |
| Hoarseness | 10 (34.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Lipase elevation | 9 (31.0) | 5 (27.8) | 3 (10.3) | 2 (11.1) |
| Anorexia | 8 (27.6) | 5 (27.8) | 1 (3.5) | 0 (0.0) |
| AST increase | 8 (27.6) | 2 (11.1) | 0 (0.0) | 0 (0.0) |
| Conjugated bilirubin increase | 7 (24.1) | 1 (5.6) | 1 (3.5) | 0 (0.0) |
| Lipase elevation | 6 (20.7) | 6 (33.3) | 2 (6.9) | 2 (11.1) |
| Platelet count decrease | 6 (20.7) | 1 (5.6) | 1 (3.5) | 0 (0.0) |
| LDH increase | 6 (20.7) | 0 (0.0) | 1 (3.5) | 0 (0.0) |
| Bilirubin increase | 5 (17.2) | 2 (11.1) | 0 (0.0) | 0 (0.0) |
| Neutrophil count decrease | 5 (17.2) | 2 (11.1) | 0 (0.0) | 0 (0.0) |
| Back pain | 5 (17.2) | 1 (5.6) | 0 (0.0) | 0 (0.0) |
| White blood cell count decrease | 4 (13.8) | 3 (16.7) | 0 (0.0) | 0 (0.0) |
| Toothache | 4 (13.8) | 3 (16.7) | 0 (0.0) | 0 (0.0) |
GGT γ-Glutamyltransferase, ALT alanine aminotransferase, AST aspartate aminotransferase, LDH lactate dehydrogenase.