Number and type of nonhematologic AEs by grade
Type of AE . | Grade 1 . | Grade 2 . | Grade 3/4 . |
|---|---|---|---|
| Constitutional | 158 (0.83) | 45 (0.23) | 9 (0.05) |
| Skin | 47 (0.25) | 21 (0.11) | 4 (0.02) |
| Gastrointestinal | 125 (0.65) | 24 (0.12) | 0 |
| Liver | NR | 9 (0.05) | 9 (0.05) |
| Edema | 77 (0.40) | 14 (0.07) | 2 (0.01) |
| Infections | 33 (0.17) | 12 (0.06) | 0 |
| Neurologic | 8 (0.04) | 8 (0.04) | 0 |
| Psychiatric | 10 (0.05) | 8 (0.04) | 0 |
| Cardiovascular | 10 (0.05) | 4 (0.02) | 3* (0.02) |
| Hemorrhage | 27 (0.14) | 5 (0.03) | 2* (0.01) |
| Other | 36 (0.19) | 6 (0.03) | 2** (0.01) |
| Total AEs | 521 (2.73) | 156 (0.81) | 31 (0.16) |
Type of AE . | Grade 1 . | Grade 2 . | Grade 3/4 . |
|---|---|---|---|
| Constitutional | 158 (0.83) | 45 (0.23) | 9 (0.05) |
| Skin | 47 (0.25) | 21 (0.11) | 4 (0.02) |
| Gastrointestinal | 125 (0.65) | 24 (0.12) | 0 |
| Liver | NR | 9 (0.05) | 9 (0.05) |
| Edema | 77 (0.40) | 14 (0.07) | 2 (0.01) |
| Infections | 33 (0.17) | 12 (0.06) | 0 |
| Neurologic | 8 (0.04) | 8 (0.04) | 0 |
| Psychiatric | 10 (0.05) | 8 (0.04) | 0 |
| Cardiovascular | 10 (0.05) | 4 (0.02) | 3* (0.02) |
| Hemorrhage | 27 (0.14) | 5 (0.03) | 2* (0.01) |
| Other | 36 (0.19) | 6 (0.03) | 2** (0.01) |
| Total AEs | 521 (2.73) | 156 (0.81) | 31 (0.16) |
The numbers of AEs are listed and, in parentheses, the frequency of the AEs (no. of AEs per patient per year). Grade 2 to 4 AEs were reported in 87 (45%) of 191 patients. In the remaining 104 patients AEs were either grade 1 or not reported at all. Constitutional symptoms included muscle cramps, myalgia, arthralgia, musculoskeletal pain, fatigue, fever, and headache. Skin symptoms were rash and related events and pruritus. Gastrointestinal symptoms included nausea, vomiting, mucositis, abdominal pain, and diarrhea. Edema was generalized, superficial, orbital, facial, or weight gain.
NR indicates not reported.
Grade 4 AEs, which were recorded 4 times