Table 2.
Incidence of adverse events with a frequency ≥4% in the study population.
| Adverse Event | Total, n (%) |
Control Group n (%) |
Experimental Group n (%) |
|---|---|---|---|
| Total AE incidence | 182 | 84 (46.2%) | 98 (53.8%) |
| Total SAE incidence | 19 (10.4%) | 12 (63.2%) | 7 (36.8%) |
| Gastrointestinal disorders | 66 (36.3%) | 39 (59.1%) | 27 (40.9%) |
| Diarrhea | 20 | 11 (55.0%) | 9 (45.0%) |
| Abdominal pain | 14 | 6 (42.9%) | 8 (57.1%) |
| Anorexia/Hyporexia | 9 | 3 (33.3%) | 6 (66.7%) |
| Ascitis | 8 | 6 (75.0%) | 2 (25.0%) |
| Gastrointestinal hemorrhage | 7 | 7 (100.0%) | 0 (0.0%) |
| General disorders | 33 (18.1%) | 15 (45.4%) | 18 (54.6%) |
| Asthenia | 20 | 11 (55.0%) | 9 (45.0%) |
| Weight loss | 8 | 2 (25.0%) | 6 (75.0%) |
| Skin and subcutaneous tissue disorders | 30 (16.5%) | 11 (36.7%) | 19 (63.3%) |
| Hand-foot syndrome | 9 | 5 (55.6%) | 4 (44.4%) |
| Rash | 8 | 1 (12.5%) | 7 (87.5%) |