Table 3.
Most Common (Incidence ≥25%) Treatment-emergent Adverse Events Overall, Overall and by Dose Group
| Dose Group
|
||||||||
|---|---|---|---|---|---|---|---|---|
| 3×105 (N=3) | 1×106 (N=3) n (%) |
3×106 (N=6) n (%) |
Total (N=12) n (%) |
|||||
|
|
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| MedDRA Preferred Term | Any Grade n (%) | Grade 3/4 n (%) | Any Grade n (%) | Grade 3/4 n (%) | Any Grade n (%) | Grade 3/4 n (%) | Any Grade n (%) | Grade 3/4 n (%) |
| Patients with At Least 1 TEAE | 3(100) | 2 (67) | 3 (100) | 2 (67) | 6 (100) | 4 (67) | 12 (100) | 8 (67) |
| Hematologic TEAEs | ||||||||
| Febrile neutropenia | 2 (67) | 2 (67) | 1 (33) | 1 (33) | 2 (33) | 1 (17) | 5 (42) | 4 (33) |
| Neutropenia/neutrophil count decreased | 0 | 0 | 1 (33) | 1 (33) | 4 (67) | 3 (50) | 5 (42) | 4 (33) |
| Thrombocytopenia/platelet count decreased | 1 (33) | 1 (33) | 1 (33) | 0 | 3 (50) | 2 (33) | 5 (42) | 3 (25) |
| White blood cell count decreased | 0 | 0 | 1 (33) | 1 (33) | 2 (33) | 3 (33) | 3 (25) | 3 (25) |
|
| ||||||||
| Non-hematologic TEAEs | ||||||||
| Fatigue | 2 (67) | 0 | 1 (33) | 0 | 3 (50) | 0 | 6 (50) | 0 |
| Anxiety | 1 (33) | 0 | 0 | 0 | 3 (50) | 0 | 4 (33) | 0 |
| Diarrhea | 0 | 0 | 2 (67) | 0 | 2 (33) | 0 | 4 (33) | 0 |
| Hypoalbuminaemia | 0 | 0 | 1 (33) | 0 | 2 (33) | 0 | 3 (25) | 0 |
| Hypotension | 1 (33) | 0 | 0 | 0 | 2 (33) | 0 | 3 (25) | 0 |