Table 2.
Overall Summary of Treatment-emergent Adverse Events, Overall and by Dose Group
Dose Group
|
||||
---|---|---|---|---|
Patients with at least 1: | 3×105 (N=3) n (%) |
1×106 (N=3) n (%) |
3×106 (N=6) n (%) |
Total (N=12) n (%) |
TEAE | 3(100) | 3 (100) | 6 (100) | 12 (100) |
Study drug-related TEAE | 3 (100) | 2 (67) | 4 (67) | 9 (75) |
Dose-limiting toxicities | 0 | 0 | 0 | 0 |
TEAE representing an infusion-related toxicity | 0 | 0 | 0 | 0 |
Grade 3 TEAE | 1 (33) | 1 (33) | 1 (17) | 3 (25) |
Grade 4 TEAE | 1 (33) | 1 (33) | 3 (50) | 5 (42) |
Grade 5 TEAE (ie, TEAE resulting in death) | 0 | 0 | 1 (17) | 1 (8) |
SAE | 1 (33) | 1 (33) | 3 (50) | 5 (42) |
TEAE leading to study discontinuation | 0 | 0 | 1 (17) | 1 (8) |