Table 3
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TEAEs Grades 3 and 4 regardless of relationship to study drug

AE30 mg (N = 7)40 mg (N = 7)Total (N = 14)
Grade 3Grade 4Grade 3Grade 4Grade 3Grade 4
n (%)n (%)n (%)n (%)n (%)n (%)
Number of patients with at least one TEAE5 (71.4)0 (0)4 (57.1)2 (28.6)9 (64.3)2 (14.3)
Neutropenia1 (14.3)0 (0)0 (0)2 (28.6)1 (7.1)2 (14.3)
Thrombocytopenia0 (0)0 (0)2 (28.6)0 (0)2 (14.3)0 (0)
Neutrophil count decreased2 (8.6)0 (0)0 (0)0 (0)2 (14.3)0 (0)
White blood cell count decreased1 (4.3)0 (0)1 (14.3)0 (0)2 (14.3)0 (0)
Anaemia1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Lymphocyte count decreased1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Enterocolitis0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Abdominal pain0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Pyrexia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Alanine aminotransferase increased0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Blood creatine phosphokinase increased1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Hyperglycaemia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Hypertriglyceridaemia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Parkinsonism1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Erythema multiforme0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Erythema nodosum0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Rash generalized1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
AE30 mg (N = 7)40 mg (N = 7)Total (N = 14)
Grade 3Grade 4Grade 3Grade 4Grade 3Grade 4
n (%)n (%)n (%)n (%)n (%)n (%)
Number of patients with at least one TEAE5 (71.4)0 (0)4 (57.1)2 (28.6)9 (64.3)2 (14.3)
Neutropenia1 (14.3)0 (0)0 (0)2 (28.6)1 (7.1)2 (14.3)
Thrombocytopenia0 (0)0 (0)2 (28.6)0 (0)2 (14.3)0 (0)
Neutrophil count decreased2 (8.6)0 (0)0 (0)0 (0)2 (14.3)0 (0)
White blood cell count decreased1 (4.3)0 (0)1 (14.3)0 (0)2 (14.3)0 (0)
Anaemia1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Lymphocyte count decreased1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Enterocolitis0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Abdominal pain0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Pyrexia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Alanine aminotransferase increased0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Blood creatine phosphokinase increased1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Hyperglycaemia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Hypertriglyceridaemia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Parkinsonism1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Erythema multiforme0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Erythema nodosum0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Rash generalized1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Table 3
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TEAEs Grades 3 and 4 regardless of relationship to study drug

AE30 mg (N = 7)40 mg (N = 7)Total (N = 14)
Grade 3Grade 4Grade 3Grade 4Grade 3Grade 4
n (%)n (%)n (%)n (%)n (%)n (%)
Number of patients with at least one TEAE5 (71.4)0 (0)4 (57.1)2 (28.6)9 (64.3)2 (14.3)
Neutropenia1 (14.3)0 (0)0 (0)2 (28.6)1 (7.1)2 (14.3)
Thrombocytopenia0 (0)0 (0)2 (28.6)0 (0)2 (14.3)0 (0)
Neutrophil count decreased2 (8.6)0 (0)0 (0)0 (0)2 (14.3)0 (0)
White blood cell count decreased1 (4.3)0 (0)1 (14.3)0 (0)2 (14.3)0 (0)
Anaemia1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Lymphocyte count decreased1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Enterocolitis0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Abdominal pain0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Pyrexia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Alanine aminotransferase increased0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Blood creatine phosphokinase increased1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Hyperglycaemia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Hypertriglyceridaemia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Parkinsonism1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Erythema multiforme0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Erythema nodosum0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Rash generalized1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
AE30 mg (N = 7)40 mg (N = 7)Total (N = 14)
Grade 3Grade 4Grade 3Grade 4Grade 3Grade 4
n (%)n (%)n (%)n (%)n (%)n (%)
Number of patients with at least one TEAE5 (71.4)0 (0)4 (57.1)2 (28.6)9 (64.3)2 (14.3)
Neutropenia1 (14.3)0 (0)0 (0)2 (28.6)1 (7.1)2 (14.3)
Thrombocytopenia0 (0)0 (0)2 (28.6)0 (0)2 (14.3)0 (0)
Neutrophil count decreased2 (8.6)0 (0)0 (0)0 (0)2 (14.3)0 (0)
White blood cell count decreased1 (4.3)0 (0)1 (14.3)0 (0)2 (14.3)0 (0)
Anaemia1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Lymphocyte count decreased1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Enterocolitis0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Abdominal pain0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Pyrexia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Alanine aminotransferase increased0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Blood creatine phosphokinase increased1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Hyperglycaemia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Hypertriglyceridaemia0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Parkinsonism1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
Erythema multiforme0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Erythema nodosum0 (0)0 (0)1 (14.3)0 (0)1 (7.1)0 (0)
Rash generalized1 (14.3)0 (0)0 (0)0 (0)1 (7.1)0 (0)
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