Table 3.
Summary of adverse events.
| Patients (n = 1465) | |
|---|---|
| Any AE of interesta | 701 (48%) |
| Treatment-emergent AEs occurring during treatment or ≤30 days after last radium-223 dose | |
| SAEs | 311 (21%) |
| SAEs resulting in death | 92 (6%) |
| Drug-related AEs | |
| Any grade | 510 (35%) |
| Grade ≥3 | 155 (11%) |
| Resulting in radium-223 discontinuation | 82 (6%) |
| Resulting in death | 9 (1%) |
| Post-treatment AEs occurring >30 days after completion of radium-223 | |
| Grade 3/4 haematological toxicities ≤6 months after completion of radium-223 | |
| Grade 3 | 203 (14%) |
| Grade 4 | 26 (2%) |
| Drug-related SAEs ≤7 years after completion of radium-223 | |
| Any SAEs | 28 (2%) |
| Resulting in death | 2 (<1%) |
AE = adverse event; SAE = serious adverse event.
a
AEs of interest were treatment-emergent SAEs and drug-related AEs during and ≤30 days after radium-223 completion, grade 3/4 haematological toxicities ≤6 months after last radium-223 dose, and drug-related SAEs after radium-223 therapy completion.