Treatment-emergent AEs, n (%) | 100Â mg | 150Â mg | 200Â mg | 300Â mg | 400Â mg | 500Â mg | 600Â mg | All patients | |
---|---|---|---|---|---|---|---|---|---|
n = 3 | n = 6 | n = 9 | n = 6 | n = 6 | n = 7 | n = 6 | n = 43 | ||
Grade 1/2a | Grade 3/4a | ||||||||
Any AE | 3 (100.0) | 6 (100.0) | 9 (100.0) | 6 (100.0) | 6 (100.0) | 7 (100.0) | 6 (100.0) | 8 (18.6) | 35 (81.4) |
Diarrhea | 2 (66.7) | 2 (33.3) | 5 (55.6) | 3 (50.0) | 6 (100.0) | 7 (100.0) | 6 (100.0) | 28 (65.1) | 3 (7.0) |
Nausea | 0 | 1 (16.7) | 2 (22.2) | 3 (50.0) | 4 (66.7) | 5 (71.4) | 4 (66.7) | 19 (44.2) | 0 |
Vomiting | 0 | 1 (16.7) | 4 (44.4) | 2 (33.3) | 3 (50.0) | 3 (42.9) | 3 (50.0) | 16 (37.2) | 0 |
Fatigue | 1 (33.3) | 1 (16.7) | 3 (33.3) | 2 (33.3) | 2 (33.3) | 3 (42.9) | 1 (16.7) | 9 (20.9) | 4 (9.3) |
Edema peripheral | 2 (66.7) | 2 (33.3) | 1 (11.1) | 0 | 2 (33.3) | 2 (28.6) | 3 (50.0) | 10 (23.3) | 2 (4.7) |
Pyrexia | 1 (33.3) | 2 (33.3) | 2 (22.2) | 1 (16.7) | 2 (33.3) | 2 (28.6) | 2 (33.3) | 9 (20.9) | 3 (7.0) |
Anemia | 0 | 1 (16.7) | 1 (11.1) | 1 (16.7) | 2 (33.3) | 2 (28.6) | 3 (50.0) | 3 (7.0) | 7 (16.3) |
Constipation | 2 (66.7) | 2 (33.3) | 2 (22.2) | 1 (16.7) | 2 (33.3) | 1 (14.3) | 1 (16.7) | 11 (25.6) | 0 |
Abdominal distension | 0 | 0 | 2 (22.2) | 1 (16.7) | 3 (50.0) | 1 (14.3) | 2 (33.3) | 9 (20.9) | 0 |
Dyspnea | 2 (66.7) | 1 (16.7) | 0 | 0 | 2 (33.3) | 1 (14.3) | 3 (50.0) | 9 (20.9) | 0 |
Asthenia | 2 (66.7) | 2 (33.3) | 1 (11.1) | 0 | 0 | 1 (14.3) | 2 (33.3) | 6 (14.0) | 2 (4.7) |
Decreased appetite | 2 (66.7) | 2 (33.3) | 0 | 0 | 3 (50.0) | 0 | 1 (16.7) | 8 (18.6) | 0 |
Epistaxis | 2 (66.7) | 1 (16.7) | 1 (11.1) | 2 (33.3) | 1 (16.7) | 0 | 1 (16.7) | 7 (16.3) | 1 (2.3) |
Thrombocytopenia | 1 (33.3) | 2 (33.3) | 0 | 1 (16.7) | 2 (33.3) | 1 (14.3) | 1 (16.7) | 2 (4.7) | 6 (14.0) |
Abdominal pain | 1 (33.3) | 1 (16.7) | 1 (11.1) | 1 (16.7) | 2 (33.3) | 0 | 1 (16.7) | 6 (14.0) | 1 (2.3) |
Back pain | 1 (33.3) | 2 (33.3) | 0 | 1 (16.7) | 2 (33.3) | 1 (14.3) | 0 | 7 (16.3) | 0 |
Insomnia | 1 (33.3) | 1 (16.7) | 2 (22.2) | 1 (16.7) | 1 (16.7) | 1 (14.3) | 0 | 7 (16.3) | 0 |
Hyperuricemia | 1 (33.3) | 1 (16.7) | 0 | 0 | 0 | 1 (14.3) | 3 (50.0) | 5 (11.6) | 1 (2.3) |
Cardiac murmur | 1 (33.3) | 0 | 1 (11.1) | 0 | 1 (16.7) | 1 (14.3) | 2 (33.3) | 6 (14.0) | 0 |
Dizziness | 0 | 0 | 2 (22.2) | 1 (16.7) | 1 (16.7) | 1 (14.3) | 1 (16.7) | 6 (14.0) | 0 |
Night sweats | 1 (33.3) | 0 | 1 (11.1) | 0 | 2 (33.3) | 1 (14.3) | 1 (16.7) | 6 (14.0) | 0 |
Neutropenia | 1 (33.3) | 2 (33.3) | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 2 (4.7) | 3 (7.0) |
Chills | 0 | 2 (33.3) | 0 | 0 | 1 (16.7) | 1 (14.3) | 1 (16.7) | 5 (11.6) | 0 |
Cough | 1 (33.3) | 1 (16.7) | 1 (11.1) | 1 (16.7) | 1 (16.7) | 0 | 0 | 5 (11.6) | 0 |
Dehydration | 0 | 1 (16.7) | 0 | 0 | 2 (33.3) | 1 (14.3) | 1 (16.7) | 5 (11.6) | 0 |
Hyperbilirubinemia | 1 (33.3) | 1 (16.7) | 1 (11.1) | 1 (16.7) | 1 (16.7) | 0 | 0 | 5 (11.6) | 0 |
Pain in extremity | 3 (100.0) | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (16.7) | 5 (11.6) | 0 |
Petechiae | 2 (66.7) | 2 (33.3) | 0 | 0 | 0 | 1 (14.3) | 0 | 5 (11.6) | 0 |
Skin lesion | 0 | 4 (66.7) | 1 (11.1) | 0 | 0 | 0 | 0 | 5 (11.6) | 0 |
Upper respiratory tract infection | 0 | 2 (33.3) | 2 (22.2) | 1 (16.7) | 0 | 0 | 0 | 5 (11.6) | 0 |