Table 3. Safety.
| Safety Population (n = 36) | ||||||
|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total | |
| Treatment-related Adverse Events, n (%) | ||||||
| Chills | 1 (2.8) | 21 (58.3) | 0 | 0 | 0 | 22 (61.1) |
| Pyrexia | 9 (25.0) | 9 (25.0) | 0 | 0 | 0 | 18 (50.0) |
| Nausea | 13 (36.1) | 4 (11.1) | 0 | 0 | 0 | 17 (47.2) |
| Hypotension | 0 | 12 (33.3) | 4 (11.1) | 0 | 0 | 16 (44.4) |
| Vomiting | 10 (27.8) | 3 (8.3) | 0 | 0 | 0 | 13 (36.1) |
| Fatigue | 8 (22.2) | 4 (11.1) | 0 | 0 | 0 | 12 (33.3) |
| Headache | 7 (19.4) | 4 (11.1) | 0 | 0 | 0 | 11 (30.6) |
| Infusion-related reaction | 0 | 6 (16.7) | 2 (5.6) | 0 | 0 | 8 (22.2) |
| Back pain | 4 (11.1) | 4 (11.1) | 0 | 0 | 0 | 8 (22.2) |
| Diarrhea | 2 (5.6) | 2 (5.6) | 1 (2.8) | 0 | 0 | 5 (13.9) |
| Abdominal distension | 1 (2.8) | 2 (5.6) | 0 | 0 | 0 | 3 (8.3) |
| Cytokine-release syndrome | 0 | 2 (5.6) | 1 (2.8) | 0 | 0 | 3 (8.3) |
| Decreased appetite | 2 (5.6) | 1 (2.8) | 0 | 0 | 0 | 3 (8.3) |
| Dizziness | 1 (2.8) | 2 (5.6) | 0 | 0 | 0 | 3 (8.3) |
| Dyspnea | 1 (2.8) | 0 | 2 (5.6) | 0 | 0 | 3 (8.3) |
| Serious treatment-related Adverse Events, n (%) | ||||||
| Total Adverse Events | 0 | 2 (5.6) | 8 (22.2) | 1 (2.8) | 0 | 11 (30.6) |
| Diarrhea | 0 | 1 (2.8) | 1 (2.8) | 0 | 0 | 2 (5.6) |
| Hypotension | 0 | 0 | 2 (5.6) | 0 | 0 | 2 (5.6) |
| Ascites | 0 | 0 | 1 (2.8) | 0 | 0 | 1 (2.8) |
| Cytokine-release syndrome | 0 | 0 | 1 (2.8) | 0 | 0 | 1 (2.8) |
| Pneumonia | 0 | 1 (2.8) | 0 | 0 | 0 | 1 (2.8) |
| Infusion-related reaction | 0 | 0 | 1 (2.8) | 0 | 0 | 1 (2.8) |
| Encephalopathy | 0 | 0 | 1 (2.8) | 0 | 0 | 1 (2.8) |
| Acute kidney injury | 0 | 0 | 1 (2.8) | 0 | 0 | 1 (2.8) |
| Respiratory failure | 0 | 0 | 0 | 1 (2.8) | 0 | 1 (2.8) |
WBC, white blood cell. Shown are treatment-related adverse events by worst grade reported in 3 or more patients and serious treatment-related adverse events by worst grade. Data are based on the entire safety population (n = 36).