Table 2.
Summary of sintilimab safety profile
| Dose | 1 mg/kg (n = 7) | 3 mg/kg (n = 15) | 10 mg/kg (n = 7) | 1 mg/kg (n = 7) | 3 mg/kg (n = 15) | 10 mg/kg (n = 7) |
|---|---|---|---|---|---|---|
| Grade | Grade1-2 | Grade1-2 | Grade1-2 | Grade 3-4 | Grade 3-4 | Grade 3-4 |
| Total number of patients | 6(85.7%) | 14(93.3%) | 6(85.7%) | 2(28.6%) | 1 (6.7%) | 0 |
| Anemia | 3(42.9%) | 5(33.3%) | 2(28.6%) | 0 | 0 | 0 |
| Fatigue | 1(14.3%) | 1(6.7%) | 0 | 0 | 0 | 0 |
| Pyrexia | 3(42.9%) | 6(40.0%) | 2(28.6%) | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 0 | 2(13.3%) | 0 | 1(14.3%) | 0 | 0 |
| Alanine aminotransferase increased | 0 | 2(13.3%) | 0 | 1(14.3%) | 0 | 0 |
| Hypothyroidism | 1(14.3%) | 2(13.3%) | 2(28.6%) | 0 | 0 | 0 |
| Hyperthyroidism | 1(14.3%) | 3(20.0%) | 0 | 0 | 0 | 0 |
| Nausea | 0 | 1(6.7%) | 0 | 0 | 0 | 0 |
| Rash, maculopapular | 1(14.3%) | 2(13.3%) | 0 | 0 | 0 | 0 |
| Diarrhoea | 0 | 1(6.7%) | 0 | 0 | 0 | 0 |
| Abdominal pain | 0 | 2(13.3%) | 1(14.3%) | 0 | 0 | 0 |
| Decreased white blood cell count | 0 | 2(13.3%) | 2(28.6%) | 0 | 0 | 0 |
| Decreased appetite | 0 | 2(13.3%) | 0 | 0 | 0 | 0 |
| Pruritus | 1(14.3%) | 3(20%) | 0 | 0 | 0 | 0 |
| Decreased platelet count | 1(14.3%) | 0 | 1(14.3%) | 1(14.3%) | 1 (6.7%) | 0 |
| Arthralgia | 0 | 1(6.7%) | 0 | 0 | 0 | 0 |
| Decreased neutrophil count | 0 | 2(13.3%) | 1(14.3%) | 0 | 0 | 0 |
| Pneumonitis | 0 | 1(6.7%) | 0 | 0 | 0 | 0 |
| Hypoalbuminemia | 1(14.3%) | 0 | 1(14.3%) | 0 | 0 | 0 |
| Hypokalaemia | 0 | 1(6.7%) | 0 | 0 | 0 | 0 |
| Hypocalcaemia | 0 | 0 | 1(14.3%) | 0 | 0 | 0 |
| Cough | 2(28.6%) | 1(6.7%) | 0 | 0 | 0 | 0 |
| Myalgia | 1(14.3%) | 1(6.7%) | 0 | 0 | 0 | 0 |
| Headache | 1(14.3%) | 2(13.3%) | 0 | 0 | 0 | 0 |
| Vomitting | 0 | 1(6.7%) | 1(14.3%) | 0 | 0 | 0 |
| Chest tightness | 1(14.3%) | 1(6.7%) | 0 | 0 | 0 | 0 |
| Constipation | 0 | 1(6.7%) | 1(14.3%) | 0 | 0 | 0 |
| Myositis | 0 | 0 | 0 | 1(14.3%) | 0 | 0 |