Table 2 (A) Grade 3 or 4 adverse events suspected to be related to study drug; (B) adverse events suspected to be related to study drug (all grades, in ≥ 10% of patients).
10 mg Reg 1 | 20 mgReg 1 | 40 mgReg 1 | 80 mgReg 1 | 150 mg Reg 1 | 300 mgReg 1 | 400 mgReg 1 | 300 mgReg 3 | 500 mgReg 3 | 700 mgReg 3 | All patients | |
---|---|---|---|---|---|---|---|---|---|---|---|
N = 3 | N = 4 | N = 4 | N = 4 | N = 4 | N = 7 | N = 5 | N = 8 | N = 6 | N = 6 | N = 51 | |
(A) Preferred term, n % | |||||||||||
Thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 4 (57.1) | 4 (80.0) | 0 | 1 (16.7) | 3 (50.0) | 12 (23.5) |
Lymphopenia | 1 (33.3) | 0 | 0 | 0 | 0 | 0 | 1 (20.0) | 1 (12.5) | 1 (16.7) | 1 (16.7) | 5 (9.8) |
Neutropenia | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 1 (20.0) | 0 | 1 (16.7) | 3 (50.0) | 6 (11.8) |
Lipase increased | 0 | 0 | 1 (25.0) | 0 | 0 | 1 (14.3) | 0 | 1 (12.5) | 1 (16.7) | 1 (16.7) | 5 (9.8) |
Leukopenia | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 2 (40.0) | 0 | 0 | 1 (16.7) | 4 (7.8) |
Anaemia | 0 | 0 | 0 | 0 | 0 | 2 (28.6) | 0 | 0 | 0 | 2 (33.3) | 4 (7.8) |
White blood cell count decreased | 0 | 0 | 0 | 0 | 0 | 3 (42.9) | 1 (20.0) | 0 | 0 | 0 | 4 (7.8) |
Granulocytopenia | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 0 | 0 | 0 | 0 | 1 (2.0) |
Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) | 1 (16.7) | 0 | 2 (3.9) |
Lymphocyte count decreased | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 0 | 0 | 0 | 0 | 1 (2.0) |
Neutrophil count decreased | 0 | 0 | 0 | 0 | 0 | 2 (28.6) | 0 | 0 | 0 | 0 | 2 (3.9) |
Hyperlipasaemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.0) |
Hyperlipidaemia | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 0 | 0 | 0 | 0 | 1 (2.0) |
Proteinuria | 0 | 0 | 0 | 0 | 0 | 0 | 1 (20.0) | 0 | 0 | 0 | 1 (2.0) |
(B) Preferred term, n % | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Thrombocytopenia | 0 | 0 | 0 | 0 | 1 (25.0) | 6 (85.7) | 5 (100.0) | 2 (25.0) | 4 (66.6) | 4 (66.6) | 22 (43) |
Nausea | 0 | 0 | 0 | 0 | 0 | 5 (71.4) | 3 (60.0) | 5 (62.5) | 5 (83.3) | 4 (66.6) | 22 (43) |
Leukopenia | 1 (33.3) | 0 | 1 (25.0) | 0 | 0 | 3 (42.8) | 4 (80.0) | 1 (12.5) | 1 (16.7) | 3 (50.0) | 14 (27) |
Fatigue | 1 (33.3) | 0 | 1 (25.0) | 0 | 0 | 4 (57.1) | 1 (20.0) | 3 (37.5) | 2 (33.3) | 1 (16.7) | 13 (26) |
Vomiting | 0 | 1 (25.0) | 0 | 0 | 0 | 2 (28.6) | 3 (60.0) | 3 (37.5) | 3 (50.0) | 2 (33.3) | 14 (27) |
Diarrhoea | 0 | 1 (25.0) | 0 | 0 | 1 (25.0) | 2 (28.6) | 2 (40.0) | 2 (25.0) | 1 (16.7) | 2 (33.3) | 11 (22) |
Neutropenia | 0 | 0 | 0 | 0 | 0 | 3 (42.8) | 3 (60.0) | 1 (12.5) | 1 (16.7) | 3 (50.0) | 11 (22) |
Lymphopenia | 1 (33.3) | 0 | 1 (25.0) | 0 | 1 (25.0) | 1 (14.3) | 1 (20.0) | 2 (25.0) | 2 (33.3) | 1 (16.7) | 10 (20) |
Decreased appetite | 0 | 0 | 0 | 0 | 0 | 3 (42.8) | 2 (40.0) | 1 (12.5) | 1 (16.7) | 2 (33.3) | 9 (18) |
Anaemia | 0 | 0 | 0 | 1 (25.0) | 0 | 2 (28.6) | 3 (60.0) | 0 | 0 | 2 (33.3) | 8 (16) |
Dysgeusia | 0 | 0 | 1 (25.0) | 0 | 0 | 0 | 0 | 2 (25.0) | 2 (33.3) | 2 (33.3) | 7 (14) |
Abdominal pain upper | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 1 (20.0) | 1 (12.5) | 2 (33.3) | 1 (16.7) | 6 (12) |
Asthenia | 1 (33.3) | 1 (25.0) | 0 | 0 | 1 (25.0) | 1 (14.3) | 1 (20.0) | 0 | 0 | 2 (33.3) | 7 (14) |
Blood CPK increased | 0 | 0 | 1 (25.0) | 1 (25.0) | 0 | 2 (28.6) | 0 | 2 (25.0) | 0 | 0 | 6 (12) |
Lipase increased | 0 | 0 | 1 (25.0) | 0 | 0 | 1 (14.3) | 1 (20.0) | 1 (12.5) | 1 (16.7) | 1 (16.7) | 6 (12) |
ALT increased | 0 | 2 (50.0) | 0 | 0 | 0 | 1 (14.3) | 1 (20.0) | 0 | 0 | 1 (16.7) | 5 (10) |
AST increased | 0 | 1 (25.0) | 0 | 0 | 1 (25.0) | 1 (14.3) | 1 (20.0) | 1 (12.5) | 0 | 0 | 5 (10) |
Dizziness | 0 | 1 (25.0) | 0 | 0 | 0 | 1 (14.3) | 1 (20.0) | 1 (12.5) | 1 (16.7) | 0 | 5 (10) |
Hypoalbuminemia | 0 | 0 | 0 | 0 | 2 (50.0) | 1 (14.3) | 1 (20.0) | 0 | 0 | 1 (16.7) | 5 (10) |