Table 2 Incidence of AEs classified by SOC and PT
System organ class | Preferred term | All grades N (%) | Grade 3 and 4 N (%) |
|---|---|---|---|
Blood and lymphatic system disorders | Anemia | 178 (89.99) | 15 (7.58) |
Leukopenia | 49 (24.75) | 0 (0) | |
Neutropenia | 58 (29.29) | 7 (3.54) | |
Thrombocytopenia | 20 (10.10) | 0 (0) | |
Investigations | Alanine aminotransferase increased | 20 (10.10) | 0 (0) |
Aspartate aminotransferase increased | 12 (6.06) | 1 (0.51) | |
Creatinine renal clearance decreased | 48 (24.24) | 0 (0) | |
Renal and urinary disorders | Renal disorder | 1 (0.51) | 0 (0) |
General disorders and administration site conditions | Drug intolerance | 1 (0.51) | 0 (0) |
No. of Patients with At Least one AE | 190 (95.96) | 22 (11.11) | |