Table 3.
Summary of safety data
| Prior chemotherapy N = 190 |
No prior chemotherapy N = 374 |
Total N = 564 |
|
|---|---|---|---|
| Any AE | 119 (63) | 181 (48) | 300 (53) |
| Drug-related TEAE | 78 (41) | 135 (36) | 213 (38) |
| Worst grade ≥ 3 | 25 (13) | 25 (7) | 50 (9) |
| Leading to permanent discontinuation of radium-223 | 17 (9) | 17 (5) | 34 (6) |
| Treatment-emergent SAE | 66 (35) | 73 (20) | 139 (25) |
| Leading to hospitalization or prolongation of existing hospitalization | 55 (29) | 63 (17) | 118 (21) |
| Leading to permanent discontinuation of radium-223 | 31 (16) | 37 (10) | 68 (12) |
| Leading to death | 24 (13) | 12 (3) | 36 (6) |
| Drug-related SAE | 13 (7) | 12 (3) | 25 (4) |
| Leading to permanent discontinuation of radium-223 | 4 (2) | 5 (1) | 9 (2) |
| Leading to death | 4 (2) | 0 | 4 (<1) |
AE adverse event, SAE serious adverse event, TEAE treatment-emergent adverse event