Table 5. Haematologic and non-haematologic adverse events per treated patient.
| Adverse events n (%) | FEC100 (n=236) | Epi-Vnr (n=233) | P-value |
|---|---|---|---|
| Neutropenia on day 21 | |||
| Grades 1–2 | 105 (44.5) | 118 (50.6) | 0.009 |
| Grades 3–4 | 41 (17.4) | 56 (24.0) | |
| Infection | |||
| Grades 1–2 | 71 (30.1) | 67 (28.8) | 0.95 |
| Grades 3–4 | 5 (2.1)a | 5 (2.1) | |
| Anemia | |||
| Grades 1–2 | 95 (40.2) | 93 (39.9) | 0.60 |
| Grade 3 | 3 (1.3) | 1 (0.4) | |
| Nausea-vomiting | |||
| Grades 1–2 | 150 (63.6) | 151 (64.8) | <0.0001 |
| Grades 3–4 | 58 (24.6) | 27 (11.6) | |
| Stomatitis | |||
| Grades 1–2 | 85 (36.0) | 49 (21.0) | 0.0007 |
| Grades 3 | 7 (3.0) | 4 (1.7) | |
| Diarrhoea | |||
| Grade 1–2 | 30 (12.7) | 24 (10.3) | 0.27 |
| Grade 3 | 0 (0.0) | 2 (0.9) | |
| Alopecia | |||
| Grades 1–2 | 49 (20.8) | 113 (48.5) | <0.0001 |
| Grade 3 | 160 (67.8) | 64 (27.5) | |
| Asthenia | |||
| Grades 1–2 | 47 (19.9) | 38 (16.3) | 0.14 |
| Grade 3 | 5 (2.1) | 1 (0.4) | |
Epi-Vnr=epirubicin–vinorelbine.
a
One patient died from a septic shock.