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Table 4 Safety profile of vinflunine in patients with TCCU progressing following first or second line chemotherapy

From: Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: an Italian multicenter study (MOVIE-GOIRC 01–2014)

Adverse events Present study N = 217 Registration study N-253
All grades n (%) Grade ≥ 3 n (%) All grades n (%) Grade ≥ 3 n (%)
Hematologic
 Neutropenia 33 (15) 19 (9) 190 (77) 123 (50)
 Febrile neutropenia 7 (3) 7 (3) 15 (6) 15 (6)
 Anemia 49 (23) 12 (6) 229 (93) 47 (19)
 Thrombocytopenia 7 (3) 2 (1) 126 (51) 14 (6)
Non-hematologic
 Constipation 48 (22) 10 (5) 118 (48) 40 (16)
 Stomatitis/mucositis 19 (9) 1 (0) 71 (29) 4 (2)
 Fatigue/asthenia 52 (24) 16 (7) 124 (50) 48 (19)
 Nausea 14 (6) 2 (1) 97 (39) 6 (2)
 Vomiting 14 (6) 2 (1) 72 (29) 7 (3)
 Neuropathy sensory 7 (3) 0 (0) 30 (12) 3 (1)
 Abdominal pain NA NA 39 (16) 10 (4)
 Alopecia NA NA 72 (29) 0 (0)
Death by toxicity   0 (0)   1 (0)
  1. NA not available