Second primary malignancies (SPMs) are defined as new malignancies unrelated to prostate cancer or progression of prostate cancer. All types of SPMs will be collected irrespectively of their relationship to Radium-223. All reported SPMs will be summarized as assessed by the physician

Safety analysis set (SAF)

Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.

Safety analysis set (SAF)

Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.

Safety analysis set (SAF)

All drug-related SAEs were collected up to 7 years after the last administration of radium-223.

Safety analysis set (SAF)

Bone marrow suppression relevant treatments for participants with subsequent chemotherapy (e.g., blood transfusion/erythropoietin/colony growth stimulating factors)

Safety analysis set (SAF)

Overall survival was defined as the time interval from the start of Radium-223 therapy to death due to any cause. Patients whose death was not confirmed at the time of data-cut were censored at the last date known to be alive.

Safety analysis set (SAF)

The Brief pain inventory short form (BPI-SF) questionnaire was used to assess pain severity on a scale from 0 (no pain) to 10 (worst pain). The BPI-SF questionnaire was requested prior to each injection of Radium-223 and also used at each follow-up visit until 6 months after the last injection of Radium-223. The pain severity score was calculated per visit. Completion of the BPI-SF questionnaire by the patient was voluntary. Since this is an observational study, the treatment regimen may not necessarily follow the recommended schedule of one cycle every 4 weeks for all participants

Safety analysis set (SAF)

The Brief pain inventory short form (BPI-SF) questionnaire was used to assess pain interference on a scale from 0 (does not interfere) to 10 (completely interferes). The BPI-SF questionnaire was requested prior to each injection of Radium-223 and also used at each follow-up visit until 6 months after the last injection of Radium-223. The pain interference score was calculated per visit. Completion of the BPI-SF questionnaire by the patient was voluntary Since this is an observational study, the treatment regimen may not necessarily follow the recommended schedule of one cycle every 4 weeks for all participants

Safety analysis set (SAF)

Bone fractures were identified by MedDRA HLGTs: Fractures: HLGT = "Fractures".

Safety analysis set (SAF)

Bone associated events were identified by MedDRA HLGTs: Bone associated events: HLGT = "Bone disorders (excl congenital and fractures)"

Safety analysis set (SAF)

Hematological toxicities were summarized by the Common Terminology Criteria for Adverse Events (CTCAE) coding system and the worst grade. The grading system ranges from Grade 1 (mild) to Grade 5 (death). The percentage of participants with post-radium-223 treatment CTCAE grade 3 or 4 hematological toxicities that occurred within 183 days from last radium-223 injection are reported

Safety analysis set (SAF)

Participants with a platelet count or WBC less than the lower limit of normal at 6 months post last dose of Radium- 223

Safety analysis set (SAF)

Participants who receive subsequent cytotoxic chemotherapy were followed for the development of febrile neutropenia and hemorrhage up to 6 months after the last administration of chemotherapy at a frequency based on local clinical practice.

Safety analysis set (SAF)