Table 2.
Adverse Events in the 82 Patients.*
| Adverse Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total |
|---|---|---|---|---|---|
| no. of patients (%) | |||||
| Any adverse event† | |||||
| Nausea | 43 (52) | 1 (1) | 0 | 0 | 44 (54) |
| Diarrhea | 38 (46) | 1 (1) | 0 | 0 | 39 (48) |
| Vomiting | 35 (43) | 1 (1) | 0 | 0 | 36 (44) |
| Visual disturbance | 34 (41) | 0 | 0 | 0 | 34 (41) |
| Constipation | 18 (22) | 2 (2) | 0 | 0 | 20 (24) |
| Peripheral edema | 13 (16) | 0 | 0 | 0 | 13 (16) |
| Dizziness | 12 (15) | 0 | 0 | 0 | 12 (15) |
| Decreased appetite | 11 (13) | 0 | 0 | 0 | 11 (13) |
| Fatigue | 8 (10) | 0 | 0 | 0 | 8 (10) |
| Grade 3 or 4 adverse events‡ | |||||
| ALT elevation | 4 (5) | 1 (1) | |||
| AST elevation | 5 (6) | 0 | |||
| Lymphopenia | 2 (2) | 0 | |||
| Hypophosphatemia | 1 (1) | 0 | |||
| Neutropenia | 1 (1) | 0 | |||
| Hypoxia | 1 (1) | 0 | |||
| Pneumonitis | 1 (1) | 0 | |||
| Pulmonary embolism | 1 (1) | 0 | |||
ALT denotes alanine aminotransferase, and AST aspartate aminotransferase.
These adverse events occurred in at least 10% of the 82 patients. The adverse events that occurred in two patients who received crizotinib during dose escalation are included. The remaining patients started treatment at 250 mg of crizotinib twice daily.
These grade 3 or 4 adverse events were evaluated in 82 patients; laboratory data were not always available for all 82 patients.