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Table 2 Summary of most common ( > 20%) adverse events and grade 3/4 adverse events in > 5% of patients

From: Final results of a phase I/II pilot study of capecitabine with or without vinorelbine after sequential dose-dense epirubicin and paclitaxel in high-risk early breast cancer

  Overall population (n = 51) Dose level 3 (recommended dose) (n = 26)
  Grade 1 Grade 2 Grade 3 Grade 4 Total Grade 1 Grade 2 Grade 3 Grade 4 Total
Alopecia 1 (2%) 38 (75%) 0 0 39 (76%) 0 24 (92%) 0 0 24 (92%)
Nausea 21 (41%) 9 (18%) 3 (6%) 2 (4%) 35 (69%) 16 (62%) 3 (12%) 1 (4%) 1 (4%) 21 (81%)
Fatigue 12 (24%) 17 (33%) 0 0 29 (57%) 8 (31%) 8 (31%) 0 0 16 (62%)
Stomatitis 18 (35%) 6 (12%) 2 (4%) 0 26 (51%) 8 (31%) 4 (15%) 2 (8%) 0 14 (54%)
Hand-foot syndrome 7 (14%) 6 (12%) 7 (14%) 0 20 (39%) 5 (19%) 4 (15%) 4 (15%) 0 13 (50%)
Nail disorder 7 (14%) 11 (22%) 0 1 (2%) 19 (37%) 4 (15%) 6 (23%) 0 0 10 (38%)
Constipation 14 (27%) 5 (10%) 0 0 19 (37%) 5 (19%) 3 (12%) 0 0 8 (31%)
Arthralgia 6 (12%) 9 (18%) 1 (2%) 0 1 (31%) 4 (15%) 3 (12%) 1 (4%) 0 8 (31%)
Bone pain 7 (14%) 5 (10%) 0 0 12 (24%) 5 (19%) 3 (12%) 0 0 8 (31%)
Paraesthesia 6 (12%) 4 (8%) 1 (2%) 1 (2%) 12 (24%) 3 (12%) 3 (12%) 0 0 6 (23%)
Diarrhoea 5 (10%) 3 (6%) 2 (4%) 2 (4%) 12 (24%) 1 (4%) 2 (8%) 1 (4%) 1 (4%) 5 (19%)
Headache 5 (10%) 4 (8%) 2 (4%) 0 11 (22%) 3 (12%) 0 1 (4%) 0 4 (15%)
Anorexia 6 (12%) 5 (10%) 0 0 11 (22%) 4 (15%) 1 (4%) 0 0 5 (19%)
Vomiting 7 (14%) 2 (4%) 4 (8%) 2 (4%) 15 (29%) 3 (12%) 0 2 (8%) 2 (8%) 7 (27%)
Febrile neutropenia 0 0 3 (6%) 3 (6%) 6 (12%) 0 0 2 (8%) 0 2 (8%)
Neutropenia 0 1 (2%) 1 (2%) 2 (4%) 4 (8%) 0 1 (4%) 1 (4%) 1 (4%) 3 (12%)
Impaired healing 0 0 1 (2%) 1 (2%) 2 (4%) 0 0 1 (4%) 1 (4%) 2 (8%)
Myalgia 6 (12%) 2 (4%) 0 0 8 (16%) 6 (23%) 1 (4%) 0 0 7 (27%)
Hypersensitivity 3 (6%) 2 (4%) 1 (2%) 0 6 (12%) 3 (12%) 2 (8%) 1 (4%) 0 6 (23%)