Table 2 Safety
AE | Total (N = 55) | |
|---|---|---|
Any grade | Grade ≥3 | |
TEAE | 55 (100.0) | 32 (58.2) |
SAE | 17 (30.9) | 13 (23.6) |
TEAE leading to discontinuation | 7 (12.7) | – |
KN046 | 6 (10.9) | – |
Lenvatinib | 4 (7.3) | – |
TEAE leading to death | 3 (5.5) | 3 (5.5) |
TRAE | 55 (100.0) | 26 (47.3) |
KN046 | 54 (98.2) | 15 (27.3) |
Lenvatinib | 54 (98.2) | 24 (43.6) |
TRSAE | 8 (14.5) | 7 (12.7) |
KN046 | 6 (10.9) | 6 (10.9) |
Lenvatinib | 5 (9.1) | 4 (7.3) |
TRAE leading to discontinuation | 5 (9.1) | – |
KN046 | 4 (7.3) | – |
Lenvatinib | 1 (1.8) | – |
TRAE leading to death | 1 (1.8) | 1 (1.8) |
irAE | 13 (23.6) | 3 (5.5) |
irAE leading to discontinuation | 1 (1.8) | – |
irAE leading to death | 1 (1.8) | 1 (1.8) |
Most common TRAE (≥10%) | ||
Platelet count decreased | 26 (47.3) | 3 (5.5) |
Hypertension | 22 (40.0) | 7 (12.7) |
Fatigue | 22 (40.0) | 2 (3.6) |
Proteinuria | 21 (38.2) | 1 (1.8) |
Elevated blood bilirubin | 19 (34.5) | 0 |
Elevated AST | 18 (32.7) | 2 (3.6) |
White blood cell decreased | 16 (29.1) | 1 (1.8) |
Infusion-related reactions | 16 (29.1) | 1 (1.8) |
Rash | 16 (29.1) | 0 |
Loss of appetite | 14 (25.5) | 0 |
Weight loss | 13 (23.6) | 2 (3.6) |
Elevated ALT | 13 (23.6) | 0 |
Hypokalemia | 12 (21.8) | 1 (1.8) |
Fever | 10 (18.2) | 0 |
Hypothyroidism | 10 (18.2) | 0 |
Hyponatremia | 9 (16.4) | 2 (3.6) |
Pruritus | 9 (16.4) | 0 |
Joint pain | 9 (16.4) | 0 |
Neutrophil count decreased | 8 (14.5) | 1 (1.8) |
Hypoalbuminemia | 8 (14.5) | 0 |
Diarrhea | 8 (14.5) | 0 |
Hypochloremia | 7 (12.7) | 0 |
Elevated blood pressure | 6 (10.9) | 5 (9.1) |
Nausea | 6 (10.9) | 0 |
Abdominal pain | 6 (10.9) | 0 |
