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Table 3 Adverse events reported in at least 20% of patients of any (safety population)

From: A randomized phase II study of paclitaxel alone versus paclitaxel plus sorafenib in second- and third-line treatment of patients with HER2-negative metastatic breast cancer (PASO)

Event (n(%))
System organ class
Preferred term
Arm A (n = 29) Arm B (n = 28)
  All Grades Grade 3/4 All Grades Grade 3/4
Blood and lymphatic system disorders 7 (24.1%) 1 (3.4%) 7 (25.0%) 3 (10.7%)
Anemia 6 (20.7%) 1 (3.4%) 6 (21.4%) 2 (7.1%)
Gastrointestinal disorders 22 (75.9%) 1 (3.4%) 26 (92.9%) 7 (25.0%)
Constipation 5 (17.2%) - 6 (21.4%) -
Diarrhea 12 (41.4%) - 16 (57.1%) 3 (10.7%)
Mucositis oral 9 (31.0%) - 12 (42.9%) -
Nausea 6 (20.7%) - 9 (32.1%) 2 (7.1%)
General disorders and administration site conditions 20 (69.0%) 1 (3.4%) 22 (78.6%) 3 (10.7%)
Edema limbs 8 (27.6%) - 1 (3.6%) -
Fatigue 13 (44.8%) - 14 (50.0%) -
Pain 8 (27.6%) - 9 (32.1%) 1 (3.6%)
Investigations 7 (24.1%) 1 (3.4%) 14 (50.0%) 9 (32.1%)
White blood cell decreased 3 (10.3%) 1 (3.4%) 12 (42.9%) 7 (25.0%)
Metabolism and nutrition disorders 3 (10.3%) 1 (3.4%) 14 (50.0%) 1 (3.6%)
Anorexia 1 (3.4%) - 12 (42.9%) 1 (3.6%)
Nervous system disorders 21 (72.4%) 3 (10.3%) 18 (64.3%) 6 (21.4%)
Dizziness 6 (20.7%) - 1 (3.6%) -
Dysgeusia 1 (3.4%) - 7 (25.0%) -
Peripheral sensory neuropathy 17 (58.6%) 2 (6.9%) 11 (39.3%) 4 (14.3%)
Respiratory, thoracic and mediastinal disorders 14 (48.3%) 1 (3.4%) 17 (60.7%) 2 (7.1%)
Epistaxis 6 (20.7%) - 7 (25.0%) -
Skin and subcutaneous tissue disorders 15 (51.7%) - 20 (71.4%) 3 (10.7%)
Alopecia 12 (41.4%) - 6 (21.4%) -