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. Author manuscript; available in PMC: 2019 Nov 15.
Published in final edited form as: Cancer. 2016 Jul 19;122(21):3327–3335. doi: 10.1002/cncr.30174

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).