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