Table 4.
Summary of the most frequent adverse events per patients.
| AE | Grade | Thigh N (%) |
Abdominal wall N (%) |
Overall N (%) |
p-value |
|---|---|---|---|---|---|
| Any AE | any | 107 (97.3) | 108 (99.1) | 215 (98.2) | 0.622 |
| 3–4 | 24 (21.8) | 27 (24.8) | 51 (23.3) | 0.634 | |
| Any hematological AE | any | 99 (90.0) | 99 (90.8) | 198 (90.4) | 1.00 |
| 3–4 | 8 (7.3) | 11 (10.1) | 19 (8.7) | 0.483 | |
| Anemia | any | 84 (76.4) | 76 (69.7) | 160 (73.1) | 0.289 |
|
3–4 |
0 (0.0) |
1 (0.9) |
1 (0.5) |
0.498 |
|
| Leukopenia | Any | 86 (78.2) | 85 (78.0) | 171 (78.1) | 1.00 |
|
3–4 |
4 (3.6) |
5 (4.6) |
9 (4.1) |
0.748 |
|
| Any non-hematological AE | any | 101 (91.8) | 102 (93.6) | 203 (92.7) | 0.796 |
| 3–4 | 17 (15.5) | 21 (19.3) | 38 (17.4) | 0.480 | |
| Increased ASAT | any | 27 (24.5) | 26 (23.9) | 53 (24.2) | 1.00 |
| 3–4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | n.a. | |
| Increased ALAT | any | 34 (30.9) | 33 (30.3) | 67 (30.6) | 1.00 |
| 3–4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | n.a. | |
| Fatigue | any | 49 (44.5) | 51 (46.8) | 100 (45.7) | 0.787 |
| 3–4 | 3 (2.7) | 0 (0.0) | 3 (1.4) | 0.247 | |
| Peripheral neuropathy | any | 54 (49.1) | 53 (48.6) | 107 (48.9) | 1.000 |
|
3–4 |
4 (3.6) |
4 (3.7) |
8 (3.7) |
1.000 |
|
| Hypersensitivity | any | 3 (2.7) | 9 (8.3) | 12 (5.5) | 0.083 |
| 3–4 | 0 (0.0) | 1 (0.9) | 1 (0.5) | 0.498 | |
| Serious adverse event | 10 | 9 | 19 | n.a. |
AE, adverse event; ALAT, alanine aminotransferase; ASAT, aspartate aminotransferase.