Table 2 AEs occurring in ≥10% of patients and any grade 3 or higher AEs
Event, n (%) | Total (N = 82) | 2.0 mg kg−1 D1D8 Q3W (N = 22) | 2.5 mg kg−1 D1D8 Q3W (N = 60) | |||
|---|---|---|---|---|---|---|
All grade | Grade ≥3 | All grade | Grade ≥3 | All grade | Grade ≥3 | |
Any TRAE | 82 (100) | 48 (58.5) | 22 (100) | 10 (45.5) | 60 (100) | 38 (63.3) |
Anemia | 70 (85.4) | 23 (28.0) | 19 (86.4) | 6 (27.3) | 51 (85.0) | 17 (28.3) |
Leukopenia | 44 (53.7) | 13 (15.9) | 10 (45.5) | 2 (9.1) | 34 (56.7) | 11 (18.3) |
Thrombocytopenia | 44 (53.7) | 12 (14.6) | 9 (40.9) | 1 (4.5) | 35 (58.3) | 11 (18.3) |
Neutropenia | 35 (42.7) | 12 (14.6) | 7 (31.8) | 2 (9.1) | 28 (46.7) | 10 (16.7) |
Nausea | 35 (42.7) | 0 | 7 (31.8) | 0 | 28 (46.7) | 0 |
Asthenia | 33 (40.2) | 2 (2.4) | 10 (45.5) | 1 (4.5) | 23 (38.3) | 1 (1.7) |
Lymphocyte count decreased | 22 (26.8) | 12 (14.6) | 4 (18.2) | 3 (13.6) | 18 (30.0) | 9 (15.0) |
Proteinuria | 21 (25.6) | 0 | 2 (9.1) | 0 | 19 (31.7) | 0 |
Decreased appetite | 18 (22.0) | 0 | 2 (9.1) | 0 | 16 (26.7) | 0 |
Hyponatremia | 17 (20.7) | 0 | 2 (9.1) | 0 | 15 (25.0) | 0 |
Hypokalemia | 15 (18.3) | 3 (3.7) | 2 (9.1) | 0 | 13 (21.7) | 3 (5.0) |
Hypoalbuminemia | 15 (18.3) | 0 | 2 (9.1) | 0 | 13 (21.7) | 0 |
Vomiting | 15 (18.3) | 0 | 1 (4.5) | 0 | 14 (23.3) | 0 |
Weight decreased | 15 (18.3) | 0 | 2 (9.1) | 0 | 13 (21.7) | 0 |
ALT increased | 13 (15.9) | 1 (1.2) | 2 (9.1) | 0 | 11 (18.3) | 1 (1.7) |
Blood alkaline phosphatase increased | 11 (13.4) | 0 | 0 | 0 | 11 (18.3) | 0 |
Stomatitis | 10 (12.2) | 0 | 0 | 0 | 10 (16.7) | 0 |
Activated partial thromboplastin time prolonged | 9 (11.0) | 0 | 3 (13.6) | 0 | 6 (10.0) | 0 |
Diarrhea | 9 (11.0) | 0 | 3 (13.6) | 0 | 6 (10.0) | 0 |
Hypophagia | 9 (11.0) | 0 | 1 (4.5) | 0 | 8 (13.3) | 0 |
Rash | 9 (11.0) | 0 | 1 (4.5) | 0 | 8 (13.3) | 0 |
Pneumonia | 7 (8.5) | 5 (6.1) | 1 (4.5) | 0 | 6 (10.0) | 5 (8.3) |
BIL conjugated increased | 6 (7.3) | 1 (1.2) | 2 (9.1) | 0 | 4 (6.7) | 1 (1.7) |
Interstitial lung disease | 3 (3.7) | 2 (2.4) | 1 (4.5) | 1 (4.5) | 2 (3.3) | 1 (1.7) |
Blood BIL increased | 2 (2.4) | 1 (1.2) | 0 | 0 | 2 (3.3) | 1 (1.7) |
Blood BIL unconjugated increased | 2 (2.4) | 1 (1.2) | 0 | 0 | 2 (3.3) | 1 (1.7) |
Atrial flutter | 1 (1.2) | 1 (1.2) | 1 (4.5) | 1 (4.5) | 0 | 0 |
Bacteremia | 1 (1.2) | 1 (1.2) | 0 | 0 | 1 (1.7) | 1 (1.7) |
Febrile neutropenia | 1 (1.2) | 1 (1.2) | 0 | 0 | 1 (1.7) | 1 (1.7) |
Gastrointestinal disorder | 1 (1.2) | 1 (1.2) | 0 | 0 | 1 (1.7) | 1 (1.7) |
Hypercalcemia | 1 (1.2) | 1 (1.2) | 1 (4.5) | 1 (4.5) | 0 | 0 |
Hypermagnesemia | 1 (1.2) | 1 (1.2) | 0 | 0 | 1 (1.7) | 1 (1.7) |
Oesophagomediastinal fistula | 1 (1.2) | 1 (1.2) | 1 (4.5) | 1 (4.5) | 0 | 0 |
