Table 5B.
Incidence of AEs of special interest, comparison between treatment arms.
| RE (N = 35) | Enza (N = 14) | a P-Value | |||||||
|---|---|---|---|---|---|---|---|---|---|
| AEs Grades | All | 1–2 | 3–4 | All | 1–2 | 3–4 | All | 3–4 | |
| Leukopenia, N (%) | 20 (57.1%) | 17 (48.6%) | 3 (8.6%) | 0 | 0 | 0 | 0.0002 | 0.55 | |
| Diarrhea, N (%) | 19 (54.3%) | 18 (51.4%) | 1 (2.9%) | 1 (7.1%) | 1 (7.1%) | 0 | 0.004 | 1.0 | |
| Fatigue, N (%) | 16 (45.7%) | 15 (42.9%) | 1 (2.9%) | 3 (21.4%) | 2 (14.3%) | 1 (7.1%) | 0.20 | 0.49 | |
| Arthralgia, N (%) | 7 (20%) | 7 (20%) | 0 | 4 (28.6%) | 3 (21.4%) | 1 (7.1%) | 0.52 | 0.49 | |
| Neutropenia, N (%) | 14 (40%) | 11 (31.4%) | 3 (8.6%) | 0 | 0 | 0 | 0.0097 | 0.55 | |
| Bone Pain, N (%) | 5 (14.3%) | 5 (14.3%) | 0 | 2 (14.3%) | 2 (14.3%) | 0 | 0.47 | 1.0 | |
| Anemia, N (%) | 9 (25.7%) | 9 (25.7%) | 0 | 1 (7.1%) | 1 (7.1%) | 0 | 0.24 | 1.0 | |
| Myalgia, N (%) | 8 (22.9%) | 8 (22.9%) | 0 | 3 (21.4%) | 3 (21.4%) | 0 | 1.0 | 1.0 | |
| Thrombocytopenia, N (%) | 7 (20.0%) | 6 (17.1%) | 1 (2.9%) | 0 | 0 | 0 | 0.17 | 1.0 | |
a
Statistical analysis was performed using Fisher’s exact test two-sided.