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. 2013 Jul 23;140(2):341–351. doi: 10.1007/s10549-013-2574-2

Table 3.

Incidence of neuropathy and sensitivity analysis of neuropathy based on a narrow definition of peripheral neuropathy by CTCAE grade (safety population)

Eribulin (n = 51), n (%) Ixabepilone (n = 50), n (%)
Neuropathya
 All grades 17 (33.3) 24 (48.0)
 Grade 1/2 12 (23.5) 13 (26.0)
 Grade 3 5 (9.8) 11 (22.0)
 Grade ≥4 0 0
Peripheral neuropathyb
 All grades 16 (31.4) 22 (44.0)
 Grade 1/2 11 (21.6) 12 (24.0)
 Grade 3 5 (9.8) 10 (20.0)
 Grade ≥4 0 0

Safety population: all patients who received at least one dose of study medication and had at least one post-dose safety assessment

CTCAE Common Terminology Criteria for Adverse Events, MedDRA Medical Dictionary for Regulatory Activities

aCombined MedDRA preferred term based on a broad list of preferred terms defined in standardized MedDRA queries for neuropathy and the following additional preferred terms: neuropathy, hyperesthesia, painful response to normal stimuli, pallanesthesia, and allodynia. If a combined term had >1 CTC grade, the highest CTC grade was used

bOf those patients with neuropathy (combined term), peripheral neuropathy was based on a narrow list of preferred terms defined in standardized MedDRA queries for neuropathy and included: neuropathy peripheral, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy, demyelinating polyneuropathy, and paresthesia