Table 2 Summary of overall safety by dose.
From: A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors
AE, n (%) | 0.2 mg/kg (n = 43) | 0.3 mg/kg (n = 145) | 0.4 mg/kg (n = 12) | All (N = 200) |
|---|---|---|---|---|
Any TEAE | 42 (98) | 144 (99) | 12 (100) | 198 (99) |
Grade 3/4 TEAE | 30 (70) | 78 (54) | 9 (75) | 117 (59) |
Drug-related TEAE | 37 (86) | 132 (91) | 12 (100) | 181 (91) |
Drug-related grade 3/4 TEAE | 20 (47) | 70 (48) | 7 (58) | 97 (49) |
SAE | 26 (60) | 77 (53) | 8 (67) | 111 (56) |
Drug-related SAEs | 9 (21) | 34 (23) | 6 (50) | 49 (25) |
TEAE leading to death | 4 (9) | 21 (14) | 2 (17) | 27 (14) |
Drug-related TEAE leading to death | 0 | 4 (3) | 2 (17) | 6 (3) |