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Table 4 Toxicities according to NCI-CTCAE Version 3.0 in the safety population

From: FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients

   LET (n = 79) n (%)   LET + ZOL (n = 89) n (%)
  Grade 1 and 2 Grade 3 and 4 Grade 1 and 2 Grade 3 and 4
Musculoskeletal and connective tissue disorders 29 (36.7) 2 (2.5) 39 (43.8) 4 (4.5)
Hot flush 25 (31.6) 2 (2.5) 19 (21.3) 0 (0.0)
Skin and subcutaneous tissue disorders 18 (22.8) 0 (0.0) 18 (20.2) 1 (1.1)
Gastrointestinal disorders 16 (20.3) 2 (2.5) 13 (14.6) 2 (2.2)
Infections and infestations 14 (17.7) 1 (1.3) 16 (18.0) 0 (0.0)
Psychiatric disorders 13 (16.5) 2 (2.5) 14 (15.7) 1 (1.1)
Fatigue 12 (15.2) 1 (1.3) 19 (21.3) 1 (1.1)
Nervous system disorders 12 (15.2) 1 (1.3) 18 (20.2) 3 (3.4)
Vertigo and Nausea 11 (13.9) 1 (1.3) 16 (18.0) 2 (2.2)
Cardiac disorders 4 (5.1) 1 (1.3) 4 (4.5) 0 (0.0)
Metabolism and nutrition disorders 4 (5.1) 0 (0.0) 10 (11.2) 0 (0.0)
Respiratory, thoracic and mediastinal disorders 3 (3.8) 1 (1.3) 4 (4.5) 2 (2.2)
Fractures 2 (2.6) 2 (2.5) 0 (0.0) 2 (2.2)
Vomiting 1 (1.3) 0 (0.0) 4 (4.5) 0 (0.0)
Pyrexia 1 (1.3) 0 (0.0) 5 (5.6) 0 (0.0)
Renal and urinary disorders 1 (1.1) 0 (0.0) 5 (6.3) 0 (0.0)
Blood and lymphatic system disorders 0 (0.0) 1 (1.3) 2 (2.2) 1 (1.1)
Hepatobiliary disorders 0 (0.0) 0 (0.0) 1 (1.1) 0 (0.0)