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) |