Table 4 Number (%) of patients with non-hematological adverse events by severity and relationship to study drug.
N = 95 | Grade 1/2 | Grade 3/4 | ||
|---|---|---|---|---|
Preferred term | total | related | Total | related |
nausea | 34(35.8) | 26(27.4) | 2(2.1) | 1(1.1) |
oedema | 8(8.4) | 8(8.4) | 2(2.1) | 1(1.1) |
oedema peripheral | 29(30.5) | 23(24.1) | -- | -- |
oedema genital | 1(1.1) | 1(1.1) | -- | |
Eyelid oedema | 23(24.2) | 23(24.2) | -- | -- |
Face oedema | 6(6.3) | 6(6.3) | -- | -- |
Periorbital edema | 8(8.4) | 8(8.4) | -- | -- |
Vomiting | 12(12.6) | 8(8.4) | 5(5.3) | 1(1.1) |
Muscle cramp | 17(17.9) | 15(15.8) | -- | -- |
Muscle spasticity | 2(2.1) | 1(1.1) | -- | -- |
Diarrhea | 25(26.3) | 19(20.0) | 1(1.1) | 1(1.1) |
Dermatitis allergic | 1(1.1) | 1(1.1) | -- | -- |
Rash | 2(2.1) | 1(1.1) | -- | -- |
Headache | 8(8.4) | 2(2.1) | 1(1.1) | 1(1.1) |
Abdominal pain | 24(25.3) | 4(4.2) | 3(3.2) | -- |
Arthralgia | 9(9.5) | 2(2.1) | 1(1.1) | -- |