Table 3:
Common Treatment Related Adverse Events With at Least 5% Incidence in Study Population
| Adverse Events | No.(%) of patients (N=58) | Cohort A1 (N=14) | Cohort A2 (N=10) | Cohort B1 (N=19) | Cohort B2 (N=16) | ||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | ||
| Lymphocyte count decreased | 38 (65.5) | 6 | 1 | 5 | 3 | 7 | 3 | 6 | 7 |
| Anemia | 20 (34.5) | 3 | 2 | 6 | 6 | 3 | |||
| Fatigue | 10 (17.2) | 1 | 2 | 7 | |||||
| Platelet count decreased | 10 (17.2) | 2 | 2 | 6 | |||||
| Rash | 9 (15.5) | 3 | 3 | 3 | |||||
| Nausea | 7 (12.1) | 1 | 3 | 2 | 1 | ||||
| Pruritus | 7 (12.1) | 2 | 3 | 2 | |||||
| AST increased | 6 (10.3) | 1 | 1 | 4 | |||||
| Vomiting | 6 (10.3) | 1 | 2 | 3 | |||||
| White blood cell decreased | 6 (10.3) | 1 | 2 | 1 | 2 | ||||
| Hypoalbuminemia | 6 (10.3) | 6 | |||||||
| Hyponatremia | 6 (10.3) | 1 | 3 | 2 | |||||
| Diarrhea | 5 (8.6) | 1 | 3 | 2 | |||||
| Fever | 5 (8.6) | 1 | 1 | 1 | 2 | ||||
| Anorexia | 4 (6.9) | 1 | 3 | ||||||
| Neutrophil count decreased | 3 (5.2) | 2 | 1 | ||||||
| Hypothyroidism | 3 (5.2) | 1 | 1 | 1 | |||||