Table 3.
The incidence of Adverse events of any cause (safety population).
| Adverse events | Any Grade-- (no,(%)) | Grade 3-- (no,(%)) | Grade 4-- (no,(%)) |
|---|---|---|---|
| Any event | 39 (97.5%) | 7 (17.5%) | 2 (5%) |
| Any event leading to discontinuation | 3 (7.5%) | 3 (7.5%) | 0 |
| Decreased white cell count | 21 (52.5%) | 3 (7.5%) | 2 (5%) |
| Decreased platelet count | 4 (10%) | 0 | 0 |
| Anemia | 25 (62.5%) | 1 (2.5%) | 0 |
| Alopecia | 14 (35%) | 0 | 0 |
| Nausea | 12 (30%) | 0 | 0 |
| Fatigue | 8 (20%) | 0 | 0 |
| Decreased appetite | 9 (22.5%) | 0 | 0 |
| Vomiting | 5 (12.5%) | 0 | 0 |
| Constipation | 4 (10%) | 0 | 0 |
| Diarrhea | 3 (7.5%) | 0 | 0 |
| Hypo-albuminemia | 2 (5%) | 0 | 0 |
| Pneumonitis | 5 (12.5%) | 2 (5%) | 0 |
| Thyroid dysfunction | 10 (25%) | 0 | 0 |
| Myocarditis | 1 (2.5%) | 0 | 0 |
| Esoenteritis | 1 (2.5%) | 1 (2.5%) | 0 |
| Esophagitis | 12 (30%) | 0 | 0 |
Multiple occurrences of the same adverse event in one patient were counted once at the highest grade for the preferred term. The incidence of treatment‑related adverse events associated with any component of the trial regimen is shown. no. (%): "no" means the number of patients who have the according adverse events, and "%" means the incidence of the according adverse events.