Table 2.
Summary of treatment-related AEs of any grade occurring in ≥ 20% of total patients or treatment-related grade 3 or worse AEs occurring in ≥ 5% of total patients (safety population)
| System organ class preferred term | Surufatinib 200 mg QD + toripalimab 240 mg Q3W (n = 6) n (%) |
Surufatinib 250 mg QD + toripalimab 240 mg Q3W (n = 12) n (%) |
Surufatinib 300 mg QD + toripalimab 240 mg Q3W (n = 12) n (%) |
Total (n = 30) n (%) |
||||
|---|---|---|---|---|---|---|---|---|
| Any Grade | ≥ Grade 3 | Any Grade | ≥ Grade 3 | Any Grade | ≥ Grade 3 | Any Grade | ≥ Grade 3 | |
| Subjects with any treatment-related AEs | 6 (100.0) | 2 (33.3) | 12 (100.0) | 4 (33.3) | 12 (100.0) | 9 (75.0) | 30 (100.0) | 15 (50.0) |
| Proteinuriaa | 6 (100.0) | 0 | 9 (75.0) | 0 | 12 (100.0) | 0 | 27 (90.0) | 0 |
| Blood bilirubin increasedb | 5 (83.3) | 0 | 9 (75.0) | 1 (8.3) | 9 (75.0) | 3 (25.0) | 23 (76.7) | 4 (13.3) |
| Fecal occult blood positivec | 5 (83.3) | 0 | 9 (75.0) | 0 | 9 (75.0) | 0 | 23 (76.7) | 0 |
| Hypertensiond | 5 (83.3) | 1 (16.7) | 6 (50.0) | 3 (25.0) | 8 (66.7) | 2 (16.7) | 19 (63.3) | 6 (20.0) |
| Blood urine presente | 1 (16.7) | 0 | 7 (58.3) | 0 | 8 (66.7) | 0 | 16 (53.3) | 0 |
| White blood cell count decreased | 4 (66.7) | 0 | 5 (41.7) | 0 | 6 (50.0) | 0 | 15 (50.0) | 0 |
| Hypothyroidism | 1 (16.7) | 0 | 4 (33.3) | 0 | 8 (66.7) | 0 | 13 (43.3) | 0 |
| Transaminases increasedf | 3 (50.0) | 1 (16.7) | 3 (25.0) | 0 | 6 (50.0) | 3 (25.0) | 12 (40.0) | 4 (13.3) |
| Anaemiag | 0 | 0 | 3 (25.0) | 1 (8.3) | 8 (66.7) | 1 (8.3) | 11 (36.7) | 2 (6.7) |
| Amylase increased | 2 (33.3) | 0 | 5 (41.7) | 0 | 2 (16.7) | 1 (8.3) | 9 (30.0) | 1 (3.3) |
| Neutrophil count decreased | 2 (33.3) | 0 | 2 (16.7) | 0 | 4 (33.3) | 0 | 8 (26.7) | 0 |
| Hyperthyroidism | 2 (33.3) | 0 | 1 (8.3) | 0 | 4 (33.3) | 1 (8.3) | 7 (23.3) | 1 (3.3) |
| Blood creatine phosphokinase increased | 1 (16.7) | 0 | 1 (8.3) | 0 | 4 (33.3) | 1 (8.3) | 6 (20.0) | 1 (3.3) |
| Blood creatine phosphokinase MB increased | 0 | 0 | 1 (8.3) | 0 | 5 (41.7) | 0 | 6 (20.0) | 0 |
| Blood urea increased | 0 | 0 | 3 (25.0) | 0 | 3 (25.0) | 0 | 6 (20.0) | 0 |
| Hypertriglyceridaemiah | 0 | 0 | 2 (16.7) | 0 | 4 (33.3) | 0 | 6 (20.0) | 0 |
| Diarrhoea | 0 | 0 | 3 (25.0) | 0 | 3 (25.0) | 0 | 6 (20.0) | 0 |
| Vomiting | 0 | 0 | 1 (8.3) | 0 | 3 (25.0) | 2 (16.7) | 4 (13.3) | 2 (6.7) |
| Asthenia | 1 (16.7) | 0 | 0 | 0 | 2 (16.7) | 2 (16.7) | 3 (10.0) | 2 (6.7) |
AE adverse event
aProteinuria included proteinuria and protein urine present
bBlood bilirubin increased included blood bilirubin increased, total bilirubin increased, direct bilirubin increased, indirect bilirubin increased, and bilirubin increased
cFecal occult blood positive included fecal occult blood positive, occult blood positive and occult blood
dHypertension included hypertension and blood pressure increased
eBlood urine present included blood urine present and red blood cells urine positive
fTransaminases increased included transaminases increased, alanine aminotransferase increased, and aspartate aminotransferase increased
gAnaemia included anaemia and haemoglobin decreased
hHypertriglyceridaemia included hypertriglyceridaemia and blood triglycerides increased