Table 2 Adverse events
All (n = 34) | Dose 3 (n = 28) | |||||
|---|---|---|---|---|---|---|
Treatment-emergent adverse events (TEAEs), n (%) | Any grade | Grade 1–2 | Grade ≥ 3 | Any grade | Grade 1–2 | Grade ≥ 3 |
Any TEAE | 34 (100.0) | 16 (47.1) | 18 (52.9) | 28 (100.0) | 13 (46.4) | 15 (53.6) |
Decreased platelet count | 16 (47.1) | 14 (41.2) | 2 (5.9) | 14 (50.0) | 13 (46.4) | 1 (3.6) |
Decreased neutrophil count | 15 (44.1) | 9 (26.5) | 6 (17.6) | 14 (50.0) | 8 (28.6) | 6 (21.4) |
Increased aspartate aminotransferase | 14 (41.2) | 13 (38.2) | 1 (2.9) | 13 (46.4) | 12 (42.9) | 1 (3.6) |
Decreased white blood cell count | 13 (38.2) | 12 (35.3) | 1 (2.9) | 11 (39.3) | 10 (35.7) | 1 (3.6) |
Increased alanine aminotransferase | 12 (35.3) | 11 (32.4) | 1 (2.9) | 11 (39.3) | 10 (35.7) | 1 (3.6) |
Hypertension | 12 (35.3) | 11 (32.4) | 1 (2.9) | 10 (35.7) | 10 (35.7) | 0 |
Fatigue | 11 (32.4) | 11 (32.4) | 0 | 9 (32.1) | 9 (32.1) | 0 |
Neurotoxicity | 11 (32.4) | 11 (32.4) | 0 | 7 (25.0) | 7 (25.0) | 0 |
Decreased appetite | 11 (32.4) | 11 (32.4) | 0 | 9 (32.1) | 9 (32.1) | 0 |
Reactive cutaneous capillary endothelial proliferation | 10 (29.4) | 10 (29.4) | 0 | 7 (25.0) | 7 (25.0) | 0 |
Anemia | 10 (29.4) | 9 (26.5) | 1 (2.9) | 8 (28.6) | 7 (25.0) | 1 (3.6) |
Proteinuria | 9 (26.5) | 8 (23.5) | 1 (2.9) | 7 (25.0) | 7 (25.0) | 0 |
Hypoalbuminemia | 9 (26.5) | 9 (26.5) | 0 | 8 (28.6) | 8 (28.6) | 0 |
Vomiting | 9 (26.5) | 8 (23.5) | 1 (2.9) | 8 (28.6) | 7 (25.0) | 1 (3.6) |
Increased blood bilirubin | 9 (26.5) | 9 (26.5) | 0 | 8 (28.6) | 8 (28.6) | 0 |
Hand-foot syndrome | 8 (23.5) | 8 (23.5) | 0 | 6 (21.4) | 6 (21.4) | 0 |
Diarrhea | 7 (20.6) | 6 (17.6) | 1 (2.9) | 6 (21.4) | 5 (17.9) | 1 (3.6) |
Hepatic function abnormal | 6 (17.6) | 1 (2.9) | 5 (14.7) | 6 (21.4) | 1 (3.6) | 5 (17.9) |
Immune-related adverse events (irAEs), n (%) | Any grade | Grade 1–2 | Grade ≥ 3 | Any grade | Grade 1–2 | Grade ≥ 3 |
|---|---|---|---|---|---|---|
Any irAE | 19 (55.9) | 14 (41.2) | 5 (14.7) | 16 (57.1) | 12 (42.9) | 4 (14.3) |
Reactive cutaneous capillary endothelial proliferation | 10 (29.4) | 10 (29.4) | 0 | 7 (25.0) | 7 (25.0) | 0 |
Rash | 5 (14.7) | 2 (5.9) | 3 (8.8) | 5 (17.9) | 2 (7.1) | 3 (10.7) |
Hypothyroidism | 4 (11.8) | 4 (11.8) | 0 | 3 (10.7) | 3 (10.7) | 0 |
Hyperthyroidism | 2 (5.9) | 2 (5.9) | 0 | 1 (3.6) | 1 (3.6) | 0 |
Immune-mediated hepatitis | 2 (5.9) | 0 | 2 (5.9) | 1 (3.6) | 0 | 1 (3.6) |
Immune-related pancreatitis | 1 (2.9) | 1 (2.9) | 0 | 1 (3.6) | 1 (3.6) | 0 |
Cushing’s syndrome | 1 (2.9) | 1 (2.9) | 0 | 1 (3.6) | 1 (3.6) | 0 |
Pituitary dysfunction | 1 (2.9) | 1 (2.9) | 0 | 1 (3.6) | 1 (3.6) | 0 |
Elevated cardiac necrosis markers | 1 (2.9) | 1 (2.9) | 0 | 0 | 0 | 0 |
