TABLE 2.
Treatment-Emergent Nonhematologic Grade ≥3 AEs Occurring in >1 Patient in All Cycles (Safety Population)
MedDRA-Preferred Term Total | Schedule 1, <1.25 mg/m2 FIL or BTZ = 1.0 N = 26 | Schedule 1, ≥1.25 mg/m2 FIL and BTZ = 1.3 N = 19 | Schedule 2 N = 10 | Total Treated N = 55 |
---|---|---|---|---|
Total no. of patients with any grade ≥3 AE (%) | 18 (69) | 12 (63) | 7 (70) | 37 (67) |
Lipase increased | 0 (0) | 4 (21) | 2 (20) | 6 (11) |
Blood amylase increased | 1 (4) | 2 (11) | 1 (10) | 4 (7) |
Pneumonia | 3 (12) | 0 (0) | 1 (10) | 4 (7) |
Cholecystitis | 1 (4) | 0 (0) | 1 (10) | 2 (4) |
Fall | 1 (4) | 0 (0) | 1 (10) | 2 (4) |
Hyperuricemia | 2 (8) | 0 (0) | 0 (0) | 2 (4) |
Hyponatremia | 2 (8) | 0 (0) | 0 (0) | 2 (4) |
Abbreviations: AE, adverse event; BTZ, bortezomib; FIL, filanesib; MedDRA, Medical Dictionary for Regulatory Activities (version 13.0).