Table 2.
Adverse events attributed (possibly, probably, or definitely) to crizotinib therapy across all strata and all dose levels
| Maximum grade of toxic effects, cycle 1 (total 65 cycles)
|
Maximum grade of toxic effects, cycles 2–33 (total 410 cycles)
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
|
Haematological toxic effects
| ||||||||||
| Anaemia | 9 (14%) | 3 (5%) | 0 | 0 | 0 | 17 (4%) | 8 (2%) | 1 (<1%) | 0 | 0 |
| Lymphocyte count decreased | 4 (6%) | 1 (2%) | 2 (3%) | 0 | 0 | 12 (3%) | 5 (1%) | 5 (1%) | 1 (<1%) | 0 |
| Neutrophil count decreased | 2 (3%) | 9 (14%) | 8 (12%) | 2 (3%) | 0 | 4 (<1%) | 9 (2%) | 11 (3%) | 6 (1%) | 0 |
| Platelet count decreased | 2 (3%) | 0 | 0 | 0 | 0 | 7 (2%) | 0 | 0 | 0 | 0 |
| White blood cell decreased | 11 (17%) | 3 (5%) | 1 (2%) | 0 | 0 | 18 (4%) | 8 (2%) | 2 (<1%) | 0 | 0 |
| Haemorrhage (intratumoral) | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (<1%) |
|
| ||||||||||
|
Non-haematological toxic effects
| ||||||||||
| Abdominal pain | 12 (18%) | 0 | 0 | 0 | 0 | 6 (1%) | 1 (<1%) | 0 | 0 | 0 |
| ALT elevation | 28 (43%) | 10 (15%) | 1 (2%) | 1 (2%) | 0 | 24 (6%) | 3 (<1%) | 2 (<1%) | 0 | 0 |
| Anorexia | 11 (17%) | 3 (5%) | 0 | 0 | 0 | 3 (<1%) | 2 (<1%) | 0 | 0 | 0 |
| AST elevation | 28 (43%) | 6 (9%) | 1 (2%) | 1 (2%) | 0 | 25 (6%) | 2 (<1%) | 1 (<1%) | 0 | 0 |
| Blurred vision | 14 (22%) | 1 (2%) | 0 | 0 | 0 | 2 (<1%) | 1 (<1%) | 0 | 0 | 0 |
| Constipation | 9 (14%) | 0 | 0 | 0 | 0 | 5 (1%) | 1 (<1%) | 0 | 0 | 0 |
| Creatinine elevation | 12 (18%) | 2 (3%) | 0 | 0 | 0 | 9 (2%) | 1 (<1%) | 0 | 0 | 0 |
| Diarrhoea | 23 (35%) | 4 (6%) | 0 | 0 | 0 | 12 (3%) | 6 (1%) | 2 (<1%) | 0 | 0 |
| Eye disorders—other, specify | 8 (12%) | 1 (2%) | 0 | 0 | 0 | 5 (1%) | 1 (<1%) | 0 | 0 | 0 |
| Fatigue | 19 (29%) | 2 (3%) | 0 | 0 | 0 | 8 (2%) | 0 | 0 | 0 | 0 |
| GGT elevated | 4 (6%) | 2 (3%) | 0 | 1 (2%) | 0 | 4 (<1%) | 1 (<1%) | 0 | 0 | 0 |
| Hypocalcaemia | 9 (14%) | 3 (5%) | 0 | 0 | 0 | 10 (2%) | 8 (2%) | 0 | 0 | 0 |
| Hyperglycaemia | 7 (11%) | 2 (3%) | 0 | 0 | 0 | 12 (3%) | 1 (<1%) | 0 | 0 | 0 |
| Hypermagnesaemia | 7 (11%) | 0 | 0 | 0 | 0 | 6 (1%) | 0 | 0 | 0 | 0 |
| Hypoalbuminaemia | 9 (14%) | 6 (9%) | 0 | 0 | 0 | 13 (3%) | 9 (2%) | 0 | 0 | 0 |
| Hypophosphataemia | 9 (14%) | 0 | 0 | 0 | 0 | 9 (2%) | 0 | 0 | 0 | 0 |
| Headache | 5 (8%) | 2 (3%) | 0 | 0 | 0 | 7 (2%) | 2 (<1%) | 0 | 0 | 0 |
| Nausea | 35 (54%) | 7 (11%) | 0 | 0 | 0 | 21 (5%) | 2 (<1%) | 0 | 0 | 0 |
| Vomiting | 32 (49%) | 5 (8%) | 1 (2%) | 0 | 0 | 16 (4%) | 3 (<1%) | 2 (<1%) | 0 | 0 |
Data are number of patients (%). Percentages are calculated as number of patients with an event divided by number of cycles of chemotherapy given. Non-haematological toxic effects are those that occurred in more than 10% of patients. ALT=alanine aminotransferase. AST=aspartate aminotransferase. GGT=gamma-glutamyl transpeptidase.