Table 2.
Table 2A, a summary of grade 3 and higher (G3+) toxicities on the two arms of the study. Table 2B, the incidence of serious adverse events (SAEs) on the two arms of the study.
| Table 2A | ||||
|---|---|---|---|---|
| Class | 6mg G3 |
6 mg G4/5 |
30mg G3 |
30mg G4/5 |
| Nausea/Vomiting | 0 | 0 | 5 (16%) | 0 |
| Low Na+ | 1 (3%) | 0 | 5 (16%) | 0 |
| Pleural Effusion | 0 | 0 | 4 (13%) | 0 |
| Pain | 6 (18%) | 0 | 4 (13%) | 0 |
| Thombosis/Embolism | 0 | 1 (3%) | 0 | 1 (3%) |
| CNS ischemia | 1 (3%) | 0 | 0 | 0 |
| Infection | 2 (6%) | 0 | 1 (3%) | 2 (6%) |
| Hypercalcemia | 0 | 0 | 2 (6%) | 0 |
| Others | 6 (18%) | 0 | 10 (31%) | 0 |
| Table 2B | |||||
|---|---|---|---|---|---|
| Arm | 0 SAE | G3 SAE | G4 SAE | G5 SAE | Total |
| 30 mg | 21 (66%) | 8 (25%) | 1 (3%) | 2 (6%) | 32 |
| 6 mg | 30 (88%) | 3 (9%) | 1 (3%) | 0 (0%) | 34 |