Skin hypopigmentation 27 (11) 0 0 0 0 0 Skin disorder 26 (11) 4 (2) 0 1 (<1) 0 0 Stomatitis 26 (11) 1 (<1) 0 4 (3) 0 0 Alopecia 25 (10) 0 0 1 (<1) 0 0 Musculoskeletal pain 23 (10) 1 (<1) 0 3 (2) 0 0 Table 6 presents laboratory abnormalities occurring in 15 % of patients who received ≥ VOTRIENT in the pivotal RCC studies. Grades are based on the NCI CTCAE. Table 6. Selected Laboratory Abnormalities in 15 % of Patients who Received ≥ VOTRIENT and More Commonly than Placebo Arm (VEG105192) VOTRIENT Placebo (N = 290) (N = 145) All Grade 3 Grade 4 All Grade Grade Grades Grades 3 4 Parameters % % % % % % Haematologic Leukopenia 37 0 0 6 0 0 Neutropenia 34 1 <1 6 0 0 Thrombocytopenia 32 <1 <1 5 0 <1 Lymphocytopenia 31 4 <1 24 1 0 Chemistry increased 53 10 2 22 1 0 AST increased 53 7 <1 19 <1 0 Glucose increased 41 <1 0 33 1 0
Skin hypopigmentation 27 (11) 0 0 0 0 0 Skin disorder 26 (11) 4 (2) 0 1 (<1) 0 0 Stomatitis 26 (11) 1 (<1) 0 4 (3) 0 0 Alopecia 25 (10) 0 0 1 (<1) 0 0 Musculoskeletal pain 23 (10) 1 (<1) 0 3 (2) 0 0 Table 6 presents laboratory abnormalities occurring in ≥ 15 % of patients who received VOTRIENT in the pivotal RCC studies. Grades are based on the NCI CTCAE. Table 6. Selected Laboratory Abnormalities in ≥ 15 % of Patients who Received VOTRIENT and More Commonly than Placebo Arm (VEG105192) VOTRIENT (N = 290) Placebo (N = 145) All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 Parameters % % % % % % Haematologic Leukopenia 37 0 0 6 0 0 Neutropenia 34 1 <1 6 0 0 Thrombocytopenia 32 <1 <1 5 0 <1 Lymphocytopenia 31 4 <1 24 1 0 Chemistry increased 53 10 2 22 1 0 AST increased 53 7 <1 19 <1 0 Glucose increased 41 <1 0 33 1 0
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