Table 2.
Most frequent TRAE in >15% of patients
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
|---|---|---|---|---|---|
| With any adverse event | 4 (10.8) | 8 (21.6) | 12 (32.4) | 4 (10.8) | 28 (75.7) |
| Cytokine release syndrome | 10 (27.0) | 6 (16.2) | 1 (2.7) | 0 | 17 (45.9) |
| Fatigue | 1 (2.7) | 9 (24.3) | 1 (2.7) | 1 (2.7) | 12 (32.4) |
| Rash | 4 (10.8) | 6 (16.2) | 2 (5.4) | 0 | 12 (32.4) |
| Injection-site reaction | 6 (16.2) | 5 (13.5) | 0 | 0 | 11 (29.7) |
| Nausea | 8 (21.6) | 1 (2.7) | 0 | 0 | 9 (24.3) |
| Pyrexia | 3 (8.1) | 4 (10.8) | 1 (2.7) | 0 | 9 (24.3)a |
| Decreased appetite | 4 (10.8) | 3 (8.1) | 0 | 0 | 7 (18.9) |
| Diarrhea | 4 (10.8) | 3 (8.1) | 0 | 0 | 7 (18.9) |
| Alanine aminotransferase increased | 4 (10.8) | 2 (5.4) | 0 | 0 | 6 (16.2) |
| Anemia | 0 | 1 (2.7) | 5 (13.5) | 0 | 6 (16.2) |
| Aspartate aminotransferase increased | 5 (13.5) | 1 (2.7) | 0 | 0 | 6 (16.2) |
| Chills | 5 (13.5) | 1 (2.7) | 0 | 0 | 6 (16.2) |
| Dyspnea | 3 (8.1) | 1 (2.7) | 2 (5.4) | 0 | 6 (16.2) |
| Platelet count decreased | 3 (8.1) | 2 (5.4) | 1 (2.7) | 0 | 6 (16.2) |
| Pruritus | 3 (8.1) | 3 (8.1) | 0 | 0 | 6 (16.2) |
Values are n (%) by Preferred Term and maximum CTCAE grade. No grade 5 AE was reported. MedDRA v26.0 coding dictionary applied.
CTCAE, Common Terminology Criteria for Adverse Events; MedDRA, Medical Dictionary for Regulatory Activities; TRAE, treatment-related adverse events.
a
Grade of one patient was unknown.