Table 3.
Frequent treatment-related adverse events occurring in ≥ 5% of the study patients (N = 38)
| Adverse events | All grades | Grade 3 or higher |
|---|---|---|
| TRAEs | ||
| Serious TRAE | 1 (2.6) | |
| Leading to anlotinib dose reduction | 19 (50.0) | |
| Leading to anlotinib treatment interruption | 4 (10.5) | |
| Leading to treatment termination | 4 (10.5) | |
| Anlotinib-related AEs causing death | 0 | |
| Hand-foot syndromea | 24 (63.2) | 9 (23.7) |
| Hypothyroidism | 23 (60.5) | 0 |
| Hypertension | 21 (55.3) | 3 (7.9) |
| Oral mucositisb | 18 (47.4) | 8 (21.1) |
| Cholesterol elevation | 17 (43.6) | 0 |
| Triglyceride elevation | 15 (39.5) | 3 (7.9) |
| Bleedingc | 13 (34.2) | 0 |
| Proteinuria | 13 (34.2) | 0 |
| Fatigue | 10 (25.6) | 0 |
| GGT elevation | 10 (26.3) | 2 (5.3) |
| Anemia | 9 (23.7) | 2 (5.3) |
| Creatine elevation | 8 (21.1) | 2 (5.3) |
| Anorexia | 7 (18.4) | 0 |
| AST elevation | 5 (13.2) | 1 (2.6) |
| ALT elevation | 4 (10.5) | 1 (2.6) |
| Nausea | 3 (7.9) | 0 |
| Neutropenia | 3 (7.9) | 1 (2.6) |
| TBIL elevation | 2 (5.3) | 1 (2.6) |
| Pharynx necrosis | 2 (5.3) | 2 (5.3) |
| Rash | 1 (2.6) | 0 |
Data are expressed in N (%)
There were two cases of pharyngeal necrosis (1 grade 3; 1 asymptomatic and intervention not indicated)
AE Adverse event, ALT Alanine aminotransferase, AST Aspartate aminotransferase, GGT Gamma-glutamyl transpeptidase, TBIL Total bilirubin, TRAE Treatment-related adverse event
aFor hand-foot syndrome, 7 patients with grade 3 TRAE lead to anlotinib dose reduction or treatment interruption
bFor oral mucositis, 6 grade 3 events required anlotinib dose reduction
cSites of grade 1–2 bleeding were the nasopharynx (n = 8), the oropharynx (n = 2), and the urinary tract (n = 3)