Table 3.
0.2 mg/kg n (%) | 0.5 mg/kg n (%) | 1.25 mg/kg n (%) | 2.1 mg/kg n (%) | 2.8 mg/kg n (%) | 3.7 mg/kg n (%) | |
---|---|---|---|---|---|---|
Evaluable pts | 2 | 2 | 2 | 4 | 96 | 6 |
Number of AEs | 1 | 1 | 6 | 28 | 475 | 27 |
Pts with AEs | 1 (50.0) | 1 (50.0) | 1 (50.0) | 4 (100.0) | 84 (87.5) | 5 (83.3) |
Pts with SAEs | 0 | 0 | 0 | 1 (25.0) | 9 (9.4) | 0 |
Pts with G3/G4 AEs | 1 (50.0) | 0 | 0 | 0 | 40 (41.7) | 3 (50.0) |
Pts discontinued due to AEs | 0 | 0 | 0 | 1 (25.0) | 2 (2.1) | 0 |
Pts with dose reduction due to AEs | 0 | 0 | 0 | 0 | 7 (7.3) | 0 |
Pts with temporary discontinuation due to AEs | 0 | 0 | 0 | 0 | 16 (16.7) | 0 |
Pts with dose reduction and temporary discontinuation due to AEs | 0 | 0 | 0 | 0 | 3 (3.1) | 1 (16.7) |
Abbreviations: AE, adverse event; Pts, patients; SAE, serious adverse event.