Table 4.
Adverse Events.
| Variable | Group RS (n=15) | Group S (n=47) | p value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| All grades (%) | Grade ≥3 (%) | All grades (%) | Grade ≥3 (%) | ||||||
| Overall | 13 | (93.3%) | 3 | (20.0%) | 43 | (91.5%) | 9 | (19.2%) | 0.82 |
| Dermatological | |||||||||
| Hand-foot syndrome | 6 | (40.0%) | 0 | (0%) | 28 | (59.6%) | 2 | (4.3%) | 0.24 |
| Other skin reaction | 10 | (66.7%) | 0 | (0%) | 13 | (27.7%) | 0 | (0%) | 0.01 |
| Hematological | |||||||||
| Leukopenia | 6 | (40.0%) | 0 | (0%) | 5 | (10.6%) | 0 | (0%) | 0.02 |
| Anemia | 3 | (20.0%) | 0 | (0%) | 4 | (8.9%) | 0 | (0%) | 0.35 |
| Thrombocytopenia | 11 | (73.3%) | 0 | (0%) | 17 | (36.2%) | 0 | (0%) | 0.02 |
| Transaminase elevation | 3 | (20.0%) | 0 | (0%) | 18 | (38.3%) | 3 | (6.4%) | 0.23 |
| Amylase elevation | 3 | (20.0%) | 0 | (0%) | 11 | (23.4%) | 0 | (0%) | 1.00 |
| Gastrointestinal | |||||||||
| Anorexia | 4 | (26.7%) | 1 | (6.7%) | 25 | (53.2%) | 1 | (2.2%) | 0.08 |
| Fatigue | 6 | (40.0%) | 1 | (6.7%) | 27 | (57.5%) | 1 | (2.2%) | 0.24 |
| Diarrhea | 4 | (26.7%) | 0 | (0%) | 24 | (51.1%) | 1 | (2.2%) | 0.14 |
| Gastrointestinal bleeding | 1 | (6.7%) | 1 | (6.7%) | 1 | (2.2%) | 1 | (2.2%) | 0.38 |