Trial Outcomes & Findings for Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer (NCT NCT02141438)

NCT ID: NCT02141438

Last Updated: 2025-10-16

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 1472 participants
• Primary outcome timeframe: From the initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223
• Results posted on: 2025-10-16

Participant Flow

The study was conducted at 188 treatment centers in 20 countries from 20 August 2014 (first patient first visit) to 02 August 2024 (last patient last visit)

Overall, 1567 participants were screened and a total of 1472 participants started treatment with Radium-223

Participant milestones

Measure	Radium-223 Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Overall Study STARTED	1472
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1450

Reasons for withdrawal

Measure	Radium-223 Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Overall Study Death	1308
Overall Study Lost to Follow-up	84
Overall Study Withdrawal by Subject	52
Overall Study Physician Decision	1
Overall Study Patients without documented end of observation due to premature site closure	5

Baseline Characteristics

Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Age, Continuous	73.0 Years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1472 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	170 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1159 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	143 Participants n=5 Participants
Race/Ethnicity, Customized White	1295 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	63 Participants n=5 Participants
Race/Ethnicity, Customized Asian	16 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	95 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223

Population: Safety analysis set (SAF)

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

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Number of Participants With Second Primary Malignancies (SPM)	24 Participants

PRIMARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223

Population: 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.

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	325 Participants

PRIMARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223

Population: 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.

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Number of Participants With Drug-related Treatment-emergent Adverse Events	537 Participants

PRIMARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks), up to 7 years after the last dose of Radium-223

Population: Safety analysis set (SAF)

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

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Number of Participants With Drug-related SAEs	88 Participants

PRIMARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after last dose of Radium-223

Population: Safety analysis set (SAF)

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

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression Patients with at least one of the bone marrow suppression relevant treatments · No	1133 Participants
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression Patients with at least one of the bone marrow suppression relevant treatments · Yes	339 Participants
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression Patients with any blood transfusions · No	1155 Participants
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression Patients with any blood transfusions · Yes	317 Participants
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression Patients receiving erythropoiesis stimulating drugs · No	1448 Participants
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression Patients receiving erythropoiesis stimulating drugs · Yes	24 Participants
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression Patients with colony stimulating factors · No	1448 Participants
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression Patients with colony stimulating factors · Yes	24 Participants

PRIMARY outcome

Timeframe: From last Radium-223 dose up to 6 months post last dose of Radium-223

Population: 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

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Incidences of Post-Radium-223 Treatment CTCAE Grade 3/4 Hematological Toxicities Based on Bone Marrow Suppression Grade 3	14.74 Percentage Interval 12.97 to 16.66
Incidences of Post-Radium-223 Treatment CTCAE Grade 3/4 Hematological Toxicities Based on Bone Marrow Suppression Grade 4	1.77 Percentage Interval 1.16 to 2.58
Incidences of Post-Radium-223 Treatment CTCAE Grade 3/4 Hematological Toxicities Based on Bone Marrow Suppression Total	15.42 Percentage Interval 13.61 to 17.37

PRIMARY outcome

Timeframe: From 30 days after last dose of Radium-223 up to 6 months after last dose

Population: 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

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC) Abnormal platelet count (<50x10^9/L) · No	398 Participants
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC) Abnormal platelet count (<50x10^9/L) · Yes	49 Participants
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC) Abnormal platelet count (<50x10^9/L) · Missing	1025 Participants
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC) Abnormal neutrophil count (<1x10^9/L) · No	247 Participants
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC) Abnormal neutrophil count (<1x10^9/L) · Yes	6 Participants
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC) Abnormal neutrophil count (<1x10^9/L) · Missing	1219 Participants

PRIMARY outcome

Timeframe: From first dose of subsequent chemotherapy up to 6 months (up to 183 days) after the last administration of chemotherapy

Population: 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.

Outcome measures

Measure	Radium-223 n=391 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Bone Marrow Suppression: Number of Participants Who Underwent Subsequent Chemotherapy That Experienced Febrile Neutropenia or Hemorrhage	23 Participants

SECONDARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223

Population: 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.

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Overall Survival	15.6 Months Interval 14.6 to 16.4

SECONDARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after the last dose of Radium-223

Population: 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

Outcome measures

Measure	Radium-223 n=1356 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Baseline/Treatment cycle 1	3.003 Score Standard Deviation 2.189
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 2 (approximately at week 4)	2.760 Score Standard Deviation 2.251
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 3 (approximately at week 8)	2.464 Score Standard Deviation 2.222
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 4 (approximately at week 12)	2.436 Score Standard Deviation 2.309
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 5 (approximately at week 16)	2.261 Score Standard Deviation 2.223
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 6 (approximately at week 20)	2.262 Score Standard Deviation 2.210
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire First available follow-up measurement	2.458 Score Standard Deviation 2.307
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Last available follow-up measurement	2.629 Score Standard Deviation 2.424

SECONDARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 4 cycles every 4 weeks) up to 6 months after the last dose of Radium-223

Population: 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

Outcome measures

Measure	Radium-223 n=1364 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Baseline/Treatment 1	3.283 Score Standard Deviation 2.664
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 2 (approximately at week 4)	2.965 Score Standard Deviation 2.588
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 3 (approximately at week 8)	2.656 Score Standard Deviation 2.469
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 4 (approximately at week 12)	2.587 Score Standard Deviation 2.525
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 5 (approximately at week 16)	2.358 Score Standard Deviation 2.408
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Treatment cycle 6 (approximately at week 20)	2.495 Score Standard Deviation 2.425
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire First available follow-up measurement	2.809 Score Standard Deviation 2.570
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire Last available follow-up measurement	3.107 Score Standard Deviation 2.774

SECONDARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223

Population: Safety analysis set (SAF)

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

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Percentage of Participants With Bone Fractures	9.7 Percentage of participants Interval 8.2 to 11.3

SECONDARY outcome

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223

Population: Safety analysis set (SAF)

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

Outcome measures

Measure	Radium-223 n=1472 Participants Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Percentage of Participants With Bone Associated Events	8.5 Percentage of participants Interval 7.1 to 10.0

Adverse Events

Radium-223

Serious events: 325 serious events

Other events: 837 other events

Deaths: 1308 deaths

Serious adverse events

Measure	Radium-223 n=1472 participants at risk Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Cardiac disorders Cardiovascular disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Anaemia	1.8% 27/1472 • Number of events 30 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Hypochromic anaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Myelosuppression	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Neutropenia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Pancytopenia	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Thrombocytopenia	0.54% 8/1472 • Number of events 8 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Bone marrow failure	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Acute myocardial infarction	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Angina pectoris	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Angina unstable	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Atrial fibrillation	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Cardiac failure	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Cardiac failure chronic	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Cardiac failure congestive	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Cardio-respiratory arrest	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Myocardial infarction	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Myocardial ischaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Ventricular fibrillation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Ear and labyrinth disorders Vertigo	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Endocrine disorders Hypercalcaemia of malignancy	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Eye disorders Papilloedema	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Abdominal pain	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Colitis	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Constipation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Crohn's disease	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Diarrhoea	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Gastric ulcer haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Gastritis erosive	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Ileus	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Intestinal obstruction	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Nausea	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Oesophagitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Proctalgia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Vomiting	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Faecaloma	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Gastrointestinal toxicity	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Diverticular perforation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Asthenia	0.54% 8/1472 • Number of events 8 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Chest pain	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Condition aggravated	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Death	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Fatigue	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Hyperthermia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Malaise	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Pain	0.68% 10/1472 • Number of events 11 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Pyrexia	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Swelling face	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Performance status decreased	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Peripheral swelling	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders General physical health deterioration	1.0% 15/1472 • Number of events 15 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Inflammation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Disease progression	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Multiple organ dysfunction syndrome	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Hepatobiliary disorders Acute hepatic failure	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Hepatobiliary disorders Bile duct stone	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Hepatobiliary disorders Cholecystitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Hepatobiliary disorders Hepatic failure	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Hepatobiliary disorders Hepatic function abnormal	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Bacteraemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Cellulitis	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Clostridium difficile colitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Cystitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Gastroenteritis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Lower respiratory tract infection	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Mastoiditis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Pneumonia	0.95% 14/1472 • Number of events 14 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Pyelonephritis	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Sepsis	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Subcutaneous abscess	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Upper respiratory tract infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Urinary tract infection	0.41% 6/1472 • Number of events 7 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Viral infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Wound infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Urosepsis	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Groin abscess	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Abscess limb	0.07% 1/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Clostridium difficile infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Staphylococcal sepsis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Acetabulum fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Ankle fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Fall	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Femoral neck fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Femur fracture	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Heat exhaustion	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Hip fracture	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Humerus fracture	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Radius fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Spinal compression fracture	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Spinal fracture	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Subdural haematoma	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Tibia fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Cervical vertebral fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Skin laceration	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Skull fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Upper limb fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Post-traumatic pain	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Craniocerebral injury	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Craniofacial fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood creatinine increased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood magnesium decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Full blood count decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Haemoglobin decreased	0.34% 5/1472 • Number of events 7 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations International normalised ratio increased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Lymphocyte count decreased	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Neutrophil count decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Platelet count decreased	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Red blood cell count decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations White blood cell count decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Eastern Cooperative Oncology Group performance status worsened	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Cachexia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Dehydration	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Failure to thrive	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypercalcaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hyperkalaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypocalcaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypokalaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypomagnesaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hyponatraemia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypophosphataemia	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Decreased appetite	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Arthralgia	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Back pain	0.75% 11/1472 • Number of events 11 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Bone pain	0.54% 8/1472 • Number of events 8 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Muscular weakness	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Pain in extremity	0.48% 7/1472 • Number of events 7 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Pathological fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Spinal pain	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia monocytic	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.1% 16/1472 • Number of events 16 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hormone-refractory prostate cancer	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour invasion	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour compression	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma metastatic	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma recurrent	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Cauda equina syndrome	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Cerebral haemorrhage	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Cerebrovascular accident	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Dizziness	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Encephalopathy	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Headache	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Hypoaesthesia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Intracranial pressure increased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Monoparesis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Nervous system disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Paraesthesia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Paraparesis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Peripheral motor neuropathy	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Presyncope	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Seizure	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Somnolence	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Spinal cord compression	0.88% 13/1472 • Number of events 14 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Superior sagittal sinus thrombosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Transient ischaemic attack	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Balance disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders IIIrd nerve paresis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Intracranial haematoma	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Spinal cord disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Epidural lipomatosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Intracranial mass	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Medullary compression syndrome	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Confusional state	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Suicide attempt	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Haematuria	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Hydronephrosis	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Nephrolithiasis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Renal failure	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Ureteric stenosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urinary bladder haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urinary retention	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urinary tract obstruction	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Acute kidney injury	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Prostatic obstruction	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Social circumstances Disability	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Surgical and medical procedures Cardiac pacemaker replacement	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Surgical and medical procedures Shoulder operation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Circulatory collapse	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Hypertension	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Hypertensive crisis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Hypotension	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Pelvic venous thrombosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Thrombosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Deep vein thrombosis	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)

Other adverse events

Measure	Radium-223 n=1472 participants at risk Participants with castration-resistant prostate cancer (CRPC) with bone metastases have received Radium-223 as part of their routine care at participating study centers
Blood and lymphatic system disorders Anaemia	11.4% 168/1472 • Number of events 193 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Aplastic anaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Haemolytic anaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Iron deficiency anaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Leukocytosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Leukopenia	1.4% 20/1472 • Number of events 21 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Lymphopenia	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Macrocytosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Myelosuppression	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Neutropenia	1.4% 21/1472 • Number of events 22 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Pancytopenia	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Pernicious anaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Thrombocytopenia	2.5% 37/1472 • Number of events 37 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Thrombocytosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Haematotoxicity	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Blood and lymphatic system disorders Bone marrow failure	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Angina pectoris	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Atrial fibrillation	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Cardiac failure	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Conduction disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Nodal arrhythmia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Palpitations	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Sinus tachycardia	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Supraventricular tachycardia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Tachycardia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Cardiac disorders Sinus node dysfunction	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Ear and labyrinth disorders Deafness	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Ear and labyrinth disorders Ear pain	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Ear and labyrinth disorders Vertigo	0.34% 5/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Ear and labyrinth disorders Cerumen impaction	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Endocrine disorders Hypothyroidism	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Eye disorders Conjunctival haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Eye disorders Diplopia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Eye disorders Exophthalmos	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Eye disorders Retinal tear	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Eye disorders Visual impairment	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Abdominal discomfort	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Abdominal distension	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Abdominal pain	0.75% 11/1472 • Number of events 11 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Abdominal pain lower	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Abdominal pain upper	0.82% 12/1472 • Number of events 14 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Aphthous ulcer	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Ascites	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Change of bowel habit	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Constipation	3.3% 49/1472 • Number of events 51 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Diarrhoea	13.8% 203/1472 • Number of events 270 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Dry mouth	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Duodenal ulcer	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Dyspepsia	0.68% 10/1472 • Number of events 10 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Dysphagia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Eructation	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Flatulence	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Frequent bowel movements	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.48% 7/1472 • Number of events 7 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Gastrointestinal pain	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Gingival pain	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Hiatus hernia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Irritable bowel syndrome	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Melaena	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Nausea	12.8% 189/1472 • Number of events 212 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Proctitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Rectal haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Salivary hypersecretion	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Toothache	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Vomiting	4.6% 67/1472 • Number of events 79 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Anal haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Hypoaesthesia oral	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Gastrointestinal motility disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Bowel movement irregularity	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Loose tooth	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Mouth swelling	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Gastrointestinal disorders Anal incontinence	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Asthenia	4.2% 62/1472 • Number of events 68 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Chest discomfort	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Chest pain	0.68% 10/1472 • Number of events 10 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Chills	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Discomfort	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Face oedema	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Facial pain	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Fatigue	11.5% 170/1472 • Number of events 182 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Feeling cold	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Gait disturbance	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Influenza like illness	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Injection site haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Malaise	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Mass	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Mucosal inflammation	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Oedema	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Oedema peripheral	2.0% 30/1472 • Number of events 31 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Pain	3.7% 55/1472 • Number of events 56 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Pyrexia	1.1% 16/1472 • Number of events 22 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Performance status decreased	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Peripheral swelling	0.48% 7/1472 • Number of events 7 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders General physical health deterioration	0.61% 9/1472 • Number of events 9 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Temperature intolerance	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Early satiety	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Inflammation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Non-cardiac chest pain	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
General disorders Illness	0.14% 2/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Hepatobiliary disorders Hepatic function abnormal	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Hepatobiliary disorders Hepatotoxicity	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Hepatobiliary disorders Hyperbilirubinaemia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Immune system disorders Hypersensitivity	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Abscess	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Bronchitis	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Conjunctivitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Conjunctivitis viral	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Cystitis	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Ear infection	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Erysipelas	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Fungal infection	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Gastroenteritis	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Herpes zoster	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Infection	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Influenza	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Labyrinthitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Localised infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Lower respiratory tract infection	0.34% 5/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Nasopharyngitis	0.54% 8/1472 • Number of events 8 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Onychomycosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Ophthalmic herpes zoster	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Osteomyelitis	0.07% 1/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Otitis externa	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Periodontitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Pneumonia	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Skin infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Tooth abscess	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Upper respiratory tract infection	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Urethritis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Urinary tract infection	0.95% 14/1472 • Number of events 14 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Urinary tract infection enterococcal	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Tooth infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Spinal cord infection	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Escherichia urinary tract infection	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Helicobacter gastritis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Staphylococcal infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Escherichia infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Oral fungal infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Respiratory tract infection viral	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Urinary tract infection staphylococcal	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Respiratory tract infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Herpes dermatitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Acarodermatitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Infections and infestations Mucosal infection	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Animal scratch	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Clavicle fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Fall	1.0% 15/1472 • Number of events 18 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Head injury	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Hip fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Humerus fracture	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Ilium fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Multiple fractures	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Muscle rupture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Rib fracture	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Spinal compression fracture	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Spinal fracture	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Wrist fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Contusion	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Joint injury	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Limb injury	0.14% 2/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Chest injury	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Upper limb fracture	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Tooth fracture	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Post-traumatic pain	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Craniocerebral injury	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Injury, poisoning and procedural complications Skin wound	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Alanine aminotransferase increased	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Aspartate aminotransferase increased	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood calcium decreased	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood creatinine increased	0.34% 5/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood glucose increased	0.14% 2/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood lactate dehydrogenase increased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood magnesium decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood potassium decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood pressure decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations C-reactive protein increased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Haematocrit decreased	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Haemoglobin decreased	1.8% 26/1472 • Number of events 40 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations International normalised ratio increased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Lymphocyte count decreased	0.75% 11/1472 • Number of events 15 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Neutrophil count decreased	0.82% 12/1472 • Number of events 13 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Platelet adhesiveness increased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Platelet count decreased	1.4% 20/1472 • Number of events 21 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Prostatic specific antigen increased	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Protein total decreased	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Red blood cell count decreased	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Weight decreased	2.4% 36/1472 • Number of events 46 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Weight increased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations White blood cell count decreased	1.5% 22/1472 • Number of events 26 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood glucose fluctuation	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Ejection fraction decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Blood alkaline phosphatase increased	0.54% 8/1472 • Number of events 8 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Eastern Cooperative Oncology Group performance status worsened	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Investigations Intestinal transit time decreased	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Cachexia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Dehydration	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypercholesterolaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hyperglycaemia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hyperkalaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypervolaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypoalbuminaemia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypocalcaemia	0.88% 13/1472 • Number of events 13 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypoglycaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypokalaemia	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hypomagnesaemia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Hyponatraemia	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Vitamin B12 deficiency	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Vitamin D deficiency	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Food aversion	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Appetite disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Decreased appetite	5.8% 85/1472 • Number of events 86 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 73/1472 • Number of events 89 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Arthropathy	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Back pain	5.8% 86/1472 • Number of events 95 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Bone disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Bone pain	3.7% 55/1472 • Number of events 56 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Coccydynia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Flank pain	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Groin pain	0.48% 7/1472 • Number of events 7 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Joint stiffness	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Joint swelling	0.34% 5/1472 • Number of events 8 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Muscle spasms	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Muscle twitching	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Muscular weakness	0.82% 12/1472 • Number of events 12 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.48% 7/1472 • Number of events 7 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Myalgia	0.54% 8/1472 • Number of events 8 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Myopathy	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Neck pain	0.54% 8/1472 • Number of events 9 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Osteonecrosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 43/1472 • Number of events 49 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Pain in jaw	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Pathological fracture	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Synovitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Tendonitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Mobility decreased	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Sacral pain	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Osteopenia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.14% 2/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.95% 14/1472 • Number of events 15 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Limb discomfort	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Spinal pain	0.61% 9/1472 • Number of events 10 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Musculoskeletal and connective tissue disorders Jaw fistula	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.34% 5/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Altered state of consciousness	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Amnesia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Areflexia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Carotid artery stenosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Carpal tunnel syndrome	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Cervicobrachial syndrome	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Disturbance in attention	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Dizziness	1.2% 17/1472 • Number of events 18 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Dysgeusia	0.82% 12/1472 • Number of events 12 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Headache	1.4% 20/1472 • Number of events 21 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Hypersomnia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Hypoaesthesia	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Hypogeusia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Lethargy	0.68% 10/1472 • Number of events 10 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Memory impairment	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Migraine	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Neuralgia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Neuropathy peripheral	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Paraesthesia	1.3% 19/1472 • Number of events 20 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Parosmia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Radiculopathy	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Sciatica	0.61% 9/1472 • Number of events 9 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Somnolence	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Spinal cord compression	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Syncope	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Tremor	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Trigeminal neuralgia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Balance disorder	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Intercostal neuralgia	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Cervical radiculopathy	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Restless legs syndrome	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Neurological decompensation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Taste disorder	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Nervous system disorders Brain fog	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Anxiety	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Bruxism	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Confusional state	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Depressed mood	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Depression	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Hallucination	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Insomnia	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Psychiatric disorders Restlessness	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Calculus urethral	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Dysuria	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Haematuria	1.2% 17/1472 • Number of events 20 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Hydronephrosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Micturition urgency	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Nephrolithiasis	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Nocturia	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Pollakiuria	0.48% 7/1472 • Number of events 7 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Proteinuria	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Renal failure	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urethral obstruction	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urge incontinence	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urinary incontinence	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urinary retention	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urinary tract disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Urine odour abnormal	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Bladder mass	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Renal impairment	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Stress urinary incontinence	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Acute kidney injury	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Renal and urinary disorders Lower urinary tract symptoms	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Pelvic pain	0.41% 6/1472 • Number of events 8 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Penile pain	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Prostatitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Pruritus genital	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Scrotal oedema	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Testicular pain	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Genital erythema	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Pelvic discomfort	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Reproductive system and breast disorders Penile oedema	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Cough	0.88% 13/1472 • Number of events 13 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 24/1472 • Number of events 24 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.41% 6/1472 • Number of events 6 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Productive cough	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Sneezing	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Wheezing	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Alopecia	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Decubitus ulcer	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Dermatitis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Ecchymosis	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Ingrowing nail	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Night sweats	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Pain of skin	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Pruritus	0.14% 2/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Purpura	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Rash	0.27% 4/1472 • Number of events 4 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.07% 1/1472 • Number of events 2 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Rash pruritic	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Skin exfoliation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Skin and subcutaneous tissue disorders Madarosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Social circumstances Bedridden	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Aortic aneurysm	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Circulatory collapse	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Hypertension	0.34% 5/1472 • Number of events 5 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Hypotension	0.61% 9/1472 • Number of events 9 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Lymphoedema	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Poor peripheral circulation	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Systolic hypertension	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Venous stenosis	0.07% 1/1472 • Number of events 1 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Deep vein thrombosis	0.20% 3/1472 • Number of events 3 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)
Vascular disorders Hot flush	0.68% 10/1472 • Number of events 11 • After initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223. Drug-related treatment-emergent adverse events (TEAEs)

Additional Information

Therapeutic Area Head

Bayer

Phone: (+) 1-888-8422937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI shall not publish results of the study before the first multi-center publication, unless agreed otherwise. If no multi-center publication occurs within 18 months after study completion, the PI may publish results at their site, provided they submit the publication to the sponsor at least 60 days prior for review and delay publication for up to 60 days if advised by the sponsor regarding patentable subject matter or Confidential Information (CI) to allow for patent filing or CI removal
• Publication restrictions are in place

Restriction type: OTHER