Table 3.
Treatment-Emergent SAEs in Safety Population (n = 129)
| MedDRA Preferred Term | NCI CTCAE Grade |
||
|---|---|---|---|
| All Grades No. (%) | 1 to 2 No. (%) | 3 to 4 No. (%) | |
| SAEs (> two patients) | 61 (47.3) | 20 (15.5) | 45 (34.9) |
| Pneumonia | 9 (7.0) | 1 (0.8) | 7 (5.4) |
| Pyrexia | 7 (5.4) | 7 (5.4) | 0 (0) |
| Infection | 4 (3.1) | 0 (0) | 4 (3.1) |
| Anemia | 3 (2.3) | 0 (0) | 3 (2.3) |
| Increased blood creatinine | 3 (2.3) | 3 (2.3) | 0 (0) |
| Multiorgan failure | 3 (2.3) | 0 (0) | 0 (0) |
| Thrombocytopenia | 3 (2.3) | 0 (0) | 3 (2.3) |
| Related SAEs (> one patient) | 27 (20.9) | 11 (8.5) | 18 (14.0) |
| Increased blood creatinine | 3 (2.3) | 3 (2.3) | 0 (0) |
| Pyrexia | 3 (2.3) | 3 (2.3) | 0 (0) |
| Thrombocytopenia | 3 (2.3) | 0 (0) | 3 (2.3) |
| Anemia | 2 (1.6) | 0 (0) | 2 (1.6) |
| Infection | 2 (1.6) | 0 (0) | 2 (1.6) |
| Pneumonia | 2 (1.6) | 0 (0) | 2 (1.6) |
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; MedDRA, Medical Dictionary for Regulatory Activities; NCI, National Cancer Institute; SAE, serious adverse event.
*
Independent central review of ECGs confirmed only two patients with grade 3 prolonged ECG QT.