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) | -- |