Table 3.
Most Frequent (≥10% of Total) Treatment-Related AEs by Grade (Safety Analysis Population)
| Patients With AE, n (%) | Crizotinib (N = 127) |
||||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4a | Total | |
| Total | 34 (26.8) | 49 (38.6) | 35 (27.6) | 5 (3.9) | 124 (97.6) |
| Elevated transaminasesb | 61 (48.0) | 15 (11.8) | 7 (5.5) | 2 (1.6) | 85 (66.9) |
| Vision disorderb | 59 (46.5) | 1 (0.8) | 0 | 0 | 61 (48.0) |
| Diarrhea | 41 (32.3) | 11 (8.7) | 1 (0.8) | 0 | 53 (41.7) |
| Nausea | 45 (35.4) | 6 (4.7) | 2 (1.6) | 0 | 53 (41.7) |
| Neutropeniab | 8 (6.3) | 20 (15.7) | 12 (9.4) | 3 (2.4) | 43 (33.9) |
| Vomiting | 39 (30.7) | 4 (3.1) | 0 | 0 | 43 (33.9) |
| Constipation | 34 (26.8) | 7 (5.5) | 0 | 0 | 41 (32.3) |
| Edemab | 30 (23.6) | 3 (2.4) | 1 (0.8) | 0 | 34 (26.8) |
| Leukopeniab | 10 (7.9) | 20 (15.7) | 3 (2.4) | 0 | 33 (26.0) |
| Blood creatinine increasedb | 19 (15.0) | 6 (4.7) | 0 | 0 | 25 (19.7) |
| Decreased appetite | 16 (12.6) | 5 (3.9) | 1 (0.8) | 0 | 22 (17.3) |
| Dysgeusia | 16 (12.6) | 1 (0.8) | 0 | 0 | 17 (13.4) |
| Fatigue | 9 (7.1) | 4 (3.1) | 2 (1.6) | 0 | 15 (11.8) |
| Bradycardiab | 11 (8.7) | 1 (0.8) | 2 (1.6) | 0 | 14 (11.0) |
| Blood alkaline phosphatase increased | 11 (8.7) | 2 (1.6) | 0 | 0 | 13 (10.2) |
AE, adverse event.
a
One patient had grade 5 AE (respiratory failure), which occurred after the primary analysis date and was considered treatment related because the investigator relationship was reported as unknown.
b
This item comprised a cluster of AEs that represent similar clinical symptoms or syndromes.