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