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. Author manuscript; available in PMC: 2011 Apr 28.
Published in final edited form as: N Engl J Med. 2010 Oct 28;363(18):1693–1703. doi: 10.1056/NEJMoa1006448

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.