Table 3. Adverse reactions associated with nilotinib administration (graded according to CTC-AE grading system) and time intervals to events.
| TOXICITY | n (%) |
|---|---|
| Every toxicity | |
| Yes | 45 (58%) |
| No | 33 (42%) |
| Hematological toxicity | 10 (13%) |
| Grade 1-2 | 10 (100%) |
| Grade 3 | 0 |
| Grade 4 | 0 |
| Type of hematological toxicity | |
| Trombocytopenia | 2 |
| Neutropenia | 2 |
| Anemia | 6 |
| Time to hematological toxicity (months)* | 1.3 (1-12) |
| Extra-hematological toxicity | 35 (45%) |
| Grade 1-2 | 17 (48%) |
| Grade 3 | 16 (46%) |
| Grade 4 | 2 (6%) |
| Type of extra-hematological toxicity | |
| Skin toxicity (rash, dry skin, erythema – grade 3, 3 pts) | 8 |
| Increase in transaminases (grade 3 in 5 pts), bilirubin (grade 3 in 2 pt) | 8 |
| Increase in amylase/lipase (grade 3 in 4 pts) | 8 |
| Increase in serum glucose/cholesterol | 3 |
| Ocular toxicity (hemorrhage, dry eye, conjunctivitis – grade 3 in 2 pts) | 3 |
| Cardio-vascular toxicity (PAOD – grade 4, hypertension) | 3 |
| CNS toxicity (migrain, stroke – grade 4) | 2 |
| Time to extra-hematological toxicity (months)* | 7.5 (0.2-85) |
| Dose reduction | |
| Yes | 39 (50%) |
| No | 39 (50%) |
| Time to dose reduction (months)* | 12 (0.2-63) |
| Nilotinib definitive discontinuation | |
| Yes | 18 (23%) |
| No | 60 (77%) |
Notes: *, values are expressed as median (min-max range)