Adverse events
| . | Month 1 . | Month 2 . | Month 3 . | Month 6 . | Month 9 . | Month 12 . |
|---|---|---|---|---|---|---|
| No. of patients treated | 37 | 37 | 37 | 35 | 34 | 34 |
| No. of patients with at least one adverse event (%) | 24 (64.9) | 18 (48.6) | 21 (56.5) | 19 (54.3) | 16 (47.0) | 17 (50.0) |
| No. of adverse events of grade ≥ 3 | 0 | 0 | 0 | 1 (grade 3) | 0 | 0 |
| Neuropsychiatric | 4 | 6 | 8 | 8 | 6 | 3 |
| Musculoskeletal | 13 | 7 | 8 | 7 | 4 | 7 |
| Gastrointestinal | 4 | 4 | 1 | 2 | 2 | 2 |
| Skin | 6 | 4 | 5 | 8 (1*)† | 5 | 5 |
| Endocrinal | 2 | 2 | 3 | 3 | 3 | 3 |
| Respiratory | — | — | 1 | 1 | — | — |
| Asthenia | 6 | 6 | 9 | 10 | 8 (1*) | 7 |
| Hematologic | 1 | 1 | 2 | 2 (1*) | — | — |
| Libido | 1 | 1 | 1 | 1 | — | — |
| Fever | 7 | 2 | 1 | 2 | 1 | 1 |
| Cardiovascular | 1 | 1 | — | 1 | — | — |
| Others‡ | — | — | — | 2 | 1 | — |
| . | Month 1 . | Month 2 . | Month 3 . | Month 6 . | Month 9 . | Month 12 . |
|---|---|---|---|---|---|---|
| No. of patients treated | 37 | 37 | 37 | 35 | 34 | 34 |
| No. of patients with at least one adverse event (%) | 24 (64.9) | 18 (48.6) | 21 (56.5) | 19 (54.3) | 16 (47.0) | 17 (50.0) |
| No. of adverse events of grade ≥ 3 | 0 | 0 | 0 | 1 (grade 3) | 0 | 0 |
| Neuropsychiatric | 4 | 6 | 8 | 8 | 6 | 3 |
| Musculoskeletal | 13 | 7 | 8 | 7 | 4 | 7 |
| Gastrointestinal | 4 | 4 | 1 | 2 | 2 | 2 |
| Skin | 6 | 4 | 5 | 8 (1*)† | 5 | 5 |
| Endocrinal | 2 | 2 | 3 | 3 | 3 | 3 |
| Respiratory | — | — | 1 | 1 | — | — |
| Asthenia | 6 | 6 | 9 | 10 | 8 (1*) | 7 |
| Hematologic | 1 | 1 | 2 | 2 (1*) | — | — |
| Libido | 1 | 1 | 1 | 1 | — | — |
| Fever | 7 | 2 | 1 | 2 | 1 | 1 |
| Cardiovascular | 1 | 1 | — | 1 | — | — |
| Others‡ | — | — | — | 2 | 1 | — |