Trial Outcomes & Findings for Radium-223 Dichloride Long-term Follow-up Program (NCT NCT02312960)

Last Updated: 2025-03-25

Results Overview

Adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

255 participants

Primary outcome timeframe

Up to 7 years

Results posted on

2025-03-25

Participant Flow

The study was conducted at multiple centers in 22 countries between 18-Dec-2014 (first participant first visit) and 31-Jan-2024 (last participant last visit).

A total of 257 participants were screened from the selected feeder studies into the 16996 study for long-term follow-up. Of these, 255 participants entered the study and 2 participants did not complete screening.

Participant milestones

Participant milestones
Measure	From Study 15396 Radium-223 Dichloride+Abi/Pred Group Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment A Group Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Overall Study STARTED	39	49	31	14	9	5	11	9	11	9	4	3	33	28
Overall Study COMPLETED	14	15	3	3	3	0	1	1	2	2	1	2	5	9
Overall Study NOT COMPLETED	25	34	28	11	6	5	10	8	9	7	3	1	28	19

Reasons for withdrawal

Reasons for withdrawal
Measure	From Study 15396 Radium-223 Dichloride+Abi/Pred Group Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment A Group Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Overall Study Death	24	32	25	11	5	5	8	5	7	3	3	1	25	19
Overall Study Missing	0	0	2	0	0	0	0	0	0	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	1	0	0	0	1	1	0	1	0	0	1	0
Overall Study Withdrawal by Subject	1	2	0	0	1	0	1	2	2	3	0	0	2	0

Baseline Characteristics

Radium-223 Dichloride Long-term Follow-up Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.	Total n=255 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	5 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	26 Participants n=36 Participants	16 Participants n=36 Participants	81 Participants n=24 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants	46 Participants n=7 Participants	28 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	10 Participants n=8 Participants	7 Participants n=24 Participants	6 Participants n=42 Participants	8 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	7 Participants n=36 Participants	12 Participants n=36 Participants	174 Participants n=24 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	14 Participants n=4 Participants	9 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	33 Participants n=36 Participants	28 Participants n=36 Participants	84 Participants n=24 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	49 Participants n=7 Participants	31 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants	11 Participants n=8 Participants	9 Participants n=24 Participants	11 Participants n=42 Participants	9 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	171 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	13 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	41 Participants n=7 Participants	31 Participants n=5 Participants	13 Participants n=4 Participants	9 Participants n=21 Participants	5 Participants n=8 Participants	11 Participants n=8 Participants	9 Participants n=24 Participants	10 Participants n=42 Participants	8 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	30 Participants n=36 Participants	27 Participants n=36 Participants	232 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants	0 Participants n=36 Participants	10 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	13 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants	5 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	10 Participants n=36 Participants	7 Participants n=36 Participants	53 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	4 Participants n=24 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	9 Participants n=4 Participants	7 Participants n=21 Participants	5 Participants n=8 Participants	7 Participants n=8 Participants	4 Participants n=24 Participants	7 Participants n=42 Participants	7 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	21 Participants n=36 Participants	20 Participants n=36 Participants	183 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants	1 Participants n=36 Participants	15 Participants n=24 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Population: SAF-LTF

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) Grade 2	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) Grade 5 (death)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Serious adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Leukemia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Myelodysplastic Syndrome	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Aplastic Anemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Primary Bone Cancer	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Any Other New Primary Malignancy	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Bone Fractures	1 Participants	2 Participants	3 Participants	1 Participants	2 Participants	0 Participants	3 Participants	6 Participants	1 Participants	1 Participants	3 Participants	0 Participants	6 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Bone-associated Events	0 Participants	1 Participants	4 Participants	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Outcome measures

Outcome measures
Measure	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 Participants Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 Participants Safety follow up from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 Participants Safety follow up from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 Participants Safety follow up from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 Participants Safety follow up from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 Participants Safety follow up from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 Participants Safety follow up from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 Participants Safety follow up from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 Participants Safety follow up from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 Participants Safety follow up from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

Adverse Events

From Study 15396 Radium-223 Dichloride+Abi/Pred Group

Serious events: 3 serious events

Other events: 2 other events

Deaths: 24 deaths

From Study 15396 Placebo+Abi/Pred Group

Serious events: 4 serious events

Other events: 6 other events

Deaths: 32 deaths

From Study 16216 Radium-223 Dichloride Group

Serious events: 4 serious events

Other events: 0 other events

Deaths: 25 deaths

From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group

Serious events: 1 serious events

Other events: 3 other events

Deaths: 11 deaths

From Study 16298 Placebo + Hormonal Therapy Group

Serious events: 1 serious events

Other events: 3 other events

Deaths: 5 deaths

From Study 16506 Radium-223 Dichloride Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

From Study 16507 Radium-223 Dichloride Treatment A Group

Serious events: 2 serious events

Other events: 1 other events

Deaths: 8 deaths

From Study 16507 Radium-223 Dichloride Treatment B Group

Serious events: 3 serious events

Other events: 1 other events

Deaths: 5 deaths

From Study 16507 Radium-223 Dichloride Treatment C Group

Serious events: 3 serious events

Other events: 3 other events

Deaths: 7 deaths

From Study 16544 Radium-223 Dichloride+Abi/Pred Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

From Study 16544 Radium-223 Dichloride+Enzalutamide Group

Serious events: 1 serious events

Other events: 1 other events

Deaths: 3 deaths

From Study 16544 Radium-223 Dichloride Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

From Study 17096 Radium-223 Dichloride + EXE/EVE Group

Serious events: 4 serious events

Other events: 8 other events

Deaths: 25 deaths

From Study 17096 Placebo + EXE/EVEgroup

Serious events: 6 serious events

Other events: 3 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 participants at risk Safety FU from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 participants at risk Safety FU from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 participants at risk Safety FU from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 participants at risk Safety FU from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 participants at risk Safety FU from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 participants at risk Safety FU from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 participants at risk Safety FU from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 participants at risk Safety FU from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 participants at risk Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 participants at risk Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 participants at risk Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 participants at risk Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 participants at risk Safety FU from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 participants at risk Safety FU from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Blood and lymphatic system disorders Aplastic anaemia	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	3.0% 1/33 • Number of events 1 • Up to 7 years	0.00% 0/28 • Up to 7 years
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	7.1% 1/14 • Number of events 2 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	11.1% 1/9 • Number of events 1 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	3.0% 1/33 • Number of events 1 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	25.0% 1/4 • Number of events 1 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/39 • Up to 7 years	2.0% 1/49 • Number of events 1 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Femur fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	3.2% 1/31 • Number of events 1 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Foot fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	3.6% 1/28 • Number of events 1 • Up to 7 years
Injury, poisoning and procedural complications Rib fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	3.6% 1/28 • Number of events 1 • Up to 7 years
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	3.6% 1/28 • Number of events 1 • Up to 7 years
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	3.0% 1/33 • Number of events 1 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 2 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Pathological fracture	2.6% 1/39 • Number of events 2 • Up to 7 years	4.1% 2/49 • Number of events 3 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	11.1% 1/9 • Number of events 1 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	11.1% 1/9 • Number of events 1 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	3.0% 1/33 • Number of events 1 • Up to 7 years	10.7% 3/28 • Number of events 5 • Up to 7 years
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	3.2% 1/31 • Number of events 1 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	3.2% 1/31 • Number of events 1 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	9.1% 1/11 • Number of events 2 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	3.2% 1/31 • Number of events 1 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/39 • Up to 7 years	2.0% 1/49 • Number of events 1 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	2.6% 1/39 • Number of events 1 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	11.1% 1/9 • Number of events 2 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Nervous system disorders Spinal cord compression	2.6% 1/39 • Number of events 1 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years

Other adverse events

Other adverse events
Measure	From Study 15396 Radium-223 Dichloride+Abi/Pred Group n=39 participants at risk Safety FU from feeder study 15396. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 15396 Placebo+Abi/Pred Group n=49 participants at risk Safety FU from feeder study 15396. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with abiraterone acetate plus prednisone/prednisolone (abi/pred) for up to 6 cycles.	From Study 16216 Radium-223 Dichloride Group n=31 participants at risk Safety FU from feeder study 16216. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group n=14 participants at risk Safety FU from feeder study 16298. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with single hormonal agent, for up to 6 cycles.	From Study 16298 Placebo + Hormonal Therapy Group n=9 participants at risk Safety FU from feeder study 16298. Participants received placebo matched to radium-223 dichloride at intervals of every 4 weeks, along with single hormonal agent for up to 6 cycles.	From Study 16506 Radium-223 Dichloride Group n=5 participants at risk Safety FU from feeder study 16506. Participants received radium-223 dichloride 50 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment A Group n=11 participants at risk Safety FU from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment B Group n=9 participants at risk Safety FU from feeder study 16507. Participants received radium-223 dichloride 88 kBg/kg at intervals of every 4 weeks for up to 6 cycles.	From Study 16507 Radium-223 Dichloride Treatment C Group n=11 participants at risk Safety follow up from feeder study 16507. Participants received radium-223 dichloride 55 kBg/kg at intervals of every 4 weeks for up to 12 cycles.	From Study 16544 Radium-223 Dichloride+Abi/Pred Group n=9 participants at risk Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with Abi/Pred for up to 6 cycles.	From Study 16544 Radium-223 Dichloride+Enzalutamide Group n=4 participants at risk Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks, along with enzalutamide for up to 6 cycles.	From Study 16544 Radium-223 Dichloride Group n=3 participants at risk Safety FU from feeder study 16544. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) at intervals of every 4 weeks for up to 6 cycles.	From Study 17096 Radium-223 Dichloride + EXE/EVE Group n=33 participants at risk Safety FU from feeder study 17096. Participants received radium-223 dichloride 50 kBg/kg (55 kBq/kg after implementation of NIST update) along with exemestane (EXE) + everolimus (EVE) once daily.	From Study 17096 Placebo + EXE/EVEgroup n=28 participants at risk Safety FU from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.
Blood and lymphatic system disorders Anaemia	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	3.0% 1/33 • Number of events 1 • Up to 7 years	0.00% 0/28 • Up to 7 years
Eye disorders Cataract	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	3.6% 1/28 • Number of events 1 • Up to 7 years
Infections and infestations Osteomyelitis	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	7.1% 1/14 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	11.1% 1/9 • Number of events 1 • Up to 7 years	0.00% 0/4 • Up to 7 years	33.3% 1/3 • Number of events 1 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/39 • Up to 7 years	2.0% 1/49 • Number of events 1 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Foot fracture	2.6% 1/39 • Number of events 1 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	7.1% 1/14 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Radius fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	11.1% 1/9 • Number of events 1 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Rib fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	7.1% 1/14 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Injury, poisoning and procedural complications Craniofacial fracture	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	25.0% 1/4 • Number of events 1 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Investigations Neutrophil count decreased	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	3.0% 1/33 • Number of events 1 • Up to 7 years	0.00% 0/28 • Up to 7 years
Investigations Platelet count decreased	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	3.0% 1/33 • Number of events 1 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/39 • Up to 7 years	2.0% 1/49 • Number of events 1 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	7.1% 1/14 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/39 • Up to 7 years	2.0% 1/49 • Number of events 2 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Pathological fracture	2.6% 1/39 • Number of events 1 • Up to 7 years	6.1% 3/49 • Number of events 3 • Up to 7 years	0.00% 0/31 • Up to 7 years	7.1% 1/14 • Number of events 1 • Up to 7 years	33.3% 3/9 • Number of events 3 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	11.1% 1/9 • Number of events 1 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	15.2% 5/33 • Number of events 10 • Up to 7 years	3.6% 1/28 • Number of events 2 • Up to 7 years
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	22.2% 2/9 • Number of events 2 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	18.2% 2/11 • Number of events 3 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/39 • Up to 7 years	2.0% 1/49 • Number of events 1 • Up to 7 years	0.00% 0/31 • Up to 7 years	7.1% 1/14 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	9.1% 3/33 • Number of events 3 • Up to 7 years	0.00% 0/28 • Up to 7 years
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	9.1% 1/11 • Number of events 1 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	3.6% 1/28 • Number of events 1 • Up to 7 years
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	3.6% 1/28 • Number of events 1 • Up to 7 years
Product Issues Device failure	0.00% 0/39 • Up to 7 years	0.00% 0/49 • Up to 7 years	0.00% 0/31 • Up to 7 years	0.00% 0/14 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/5 • Up to 7 years	0.00% 0/11 • Up to 7 years	11.1% 1/9 • Number of events 1 • Up to 7 years	0.00% 0/11 • Up to 7 years	0.00% 0/9 • Up to 7 years	0.00% 0/4 • Up to 7 years	0.00% 0/3 • Up to 7 years	0.00% 0/33 • Up to 7 years	0.00% 0/28 • Up to 7 years

Additional Information

Therapeutic Area Head

Bayer

Phone: (+) 1-888-8422937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60