Table 7.
Serious treatment-emergent adverse events (with an incidence of ≥2 events in the study)
| MedDRA, version 14.1, preferred term | Phase I totala (N = 9) | Phase II 160 mg (N = 38) |
|---|---|---|
| Overall | 2 (22.2) | 13 (34.2) |
| Cancer pain | 1 (11.1) | 2 (5.3) |
| Anemia | 0 | 2 (5.3) |
| Disseminated intravascular coagulation | 0 | 2 (5.3) |
| General physical health deterioration | 0 | 2 (5.3) |
| Cellulitis | 0 | 2 (5.3) |
| Tumor pain | 0 | 2 (5.3) |
| Bladder tamponade | 0 | 2 (5.3) |
Number of patients (%)
MedDRA Medical Dictionary for Regulatory Activities
aIn phase I, safety data from single doses (80, 160 and 240 mg) and multiple doses (80 and 160 mg) are included. All patients in the 240 mg group received enzalutamide at a dose of 160 mg after single dosing