Table 2.
Treatment-related adverse events (TRAEs) in the safety set (N=20).
| n (%) | ||||
|---|---|---|---|---|
| Any TRAEs | 20 (100.0) | |||
| Grade 3 TRAEs | 8 (40.0) | |||
| Grade 4-5 TRAEs | 0 | |||
| TRAEs leading to Sintilimab interruptions | 2 (10.0) | |||
| TRAEs leading to Anlotinib interruptions | 6 (30.0) | |||
| TRAEs leading to Anlotinib dose modification | 12 (60.0) | |||
| TRAEs leading to treatment discontinuation | 1 (5.0) | |||
| Most common TRAEs* | n (%) | |||
| Any Grade | Grade1 | Grade2 | Grade3 | |
| Proteinuria | 11 (55.0) | 8 (40.0) | 2 (10.0) | 1 (5.0) |
| Hypoproteinemia | 10 (50.0) | 10 (50.0) | 0 | 0 |
| Platelet count decreased | 10 (50.0) | 6 (30.0) | 2 (10.0) | 2 (10.0) |
| Hand-foot syndrome | 8 (40.0) | 5 (25.0) | 2 (10.0) | 1 (5.0) |
| AST increased | 7 (35.0) | 6 (30.0) | 0 | 1 (5.0) |
| Hypertension | 7 (35.0) | 2 (10.0) | 5 (25.0) | 0 |
| ALT increased | 6 (30.0) | 6 (30.0) | 0 | 0 |
| Neutrophil counts decreased | 5 (25.0) | 3 (15.0) | 2 (10.0) | 0 |
| Leucocyte count decreased | 5 (25.0) | 2 (10.0) | 3 (15.0) | 0 |
| Elevated bilirubin | 4 (20.0) | 2 (10.0) | 2 (10.0) | 0 |
| Hyponatremia | 4 (20.0) | 4 (20.0) | 0 | 0 |
| Hypokalemia | 4 (20.0) | 3 (15.0) | 0 | 1 (5.0) |
| Hypothyroidism | 4 (20.0) | 0 | 3 (15.0) | 1 (5.0) |
| γ-GT increased | 3 (15.0) | 1 (5.0) | 0 | 2 (10.0) |
| Arthrodynia | 3 (15.0) | 1 (5.0) | 2 (10.0) | 0 |
| Sore throat | 3 (15.0) | 2 (10.0) | 1 (5.0) | 0 |
| Bullous dermatitis | 2 (10.0) | 1 (5.0) | 0 | 1 (5.0) |
ALT, alanine transaminase; AST, aspartate transaminase; γ-GT, γ-glutamyl transferase.
*Listed are adverse events, as defined by the Common Toxicity Standards of the National Cancer Institute (version 5.0) that occurred in at least 10% of patients in the safety set.