Nonhematologic adverse events regardless of relationship to treatment reported by >10% of patients in the safety population (N = 42)
| . | Patients, n (%) . | |||
|---|---|---|---|---|
| Preferred term* . | Grade 1-2 . | Grade 3 . | Grade 4-5 . | Total . | 
| Nausea | 11 (26.2) | 2 (4.8) | 0 (0) | 13 (31.0) | 
| Chills | 10 (23.8) | 0 (0) | 0 (0) | 10 (23.8) | 
| Infusion-related reaction | 9 (21.4) | 0 (0) | 0 (0) | 9 (21.4) | 
| Headache | 9 (21.4) | 0 (0) | 0 (0) | 9 (21.4) | 
| Pyrexia | 8 (19.0) | 0 (0) | 0 (0) | 8 (19.0) | 
| Fatigue | 7 (16.7) | 0 (0) | 0 (0) | 7 (16.7) | 
| Cutaneous drug eruption | 6 (14.3) | 1 (2.4) | 0 (0) | 7 (16.7) | 
| Diarrhea | 5 (11.9) | 1 (2.4) | 0 (0) | 6 (14.3) | 
| Pruritus | 5 (11.9) | 0 (0) | 0 (0) | 5 (11.9) | 
| Upper respiratory tract infection | 5 (11.9) | 0 (0) | 0 (0) | 5 (11.9) | 
| Vomiting | 3 (7.1) | 2 (4.8) | 0 (0) | 5 (11.9) | 
| . | Patients, n (%) . | |||
|---|---|---|---|---|
| Preferred term* . | Grade 1-2 . | Grade 3 . | Grade 4-5 . | Total . | 
| Nausea | 11 (26.2) | 2 (4.8) | 0 (0) | 13 (31.0) | 
| Chills | 10 (23.8) | 0 (0) | 0 (0) | 10 (23.8) | 
| Infusion-related reaction | 9 (21.4) | 0 (0) | 0 (0) | 9 (21.4) | 
| Headache | 9 (21.4) | 0 (0) | 0 (0) | 9 (21.4) | 
| Pyrexia | 8 (19.0) | 0 (0) | 0 (0) | 8 (19.0) | 
| Fatigue | 7 (16.7) | 0 (0) | 0 (0) | 7 (16.7) | 
| Cutaneous drug eruption | 6 (14.3) | 1 (2.4) | 0 (0) | 7 (16.7) | 
| Diarrhea | 5 (11.9) | 1 (2.4) | 0 (0) | 6 (14.3) | 
| Pruritus | 5 (11.9) | 0 (0) | 0 (0) | 5 (11.9) | 
| Upper respiratory tract infection | 5 (11.9) | 0 (0) | 0 (0) | 5 (11.9) | 
| Vomiting | 3 (7.1) | 2 (4.8) | 0 (0) | 5 (11.9) | 
Using MedDRA Version 12.0.