Radium-223 Dichloride Long-term Follow-up Program | NCT02312960

ID	Type	Description	Link
2014-002407-25	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Other	The subjects previously enrolled in a selected radium-223 dichloride feeder trial, their treating health care professional, or caregiver will be contacted in 6-month intervals for follow up and query.	Other: Data Collection

Name	Type	Description	Arm Group Labels	Other Names
Data Collection	Other	No study treatment will be provided in this long term follow up study.	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)	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.	Up to 7 years
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)	Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)	Up to 7 years
Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events	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.	Up to 7 years
Number of Participants With Leukemia		Up to 7 years
Number of Participants With Myelodysplastic Syndrome		Up to 7 years
Number of Participants With Aplastic Anemia		Up to 7 years
Number of Participants With Primary Bone Cancer		Up to 7 years
Number of Participants With Any Other New Primary Malignancy		Up to 7 years

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Anchorage	Alaska	99503	United States

References Module

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 11, 2018	Jan 8, 2025

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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.
BG004	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.
BG005	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.
BG006	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.
BG007	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.
BG008	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.
BG009	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.
BG010	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.
BG011	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.
BG012	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.
BG013	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.
BG014	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0014 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)

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.

SAF-LTF

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.
OG004	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.
OG005	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.
OG006	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.
OG007	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.
OG008	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.
OG009	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.
OG010	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.
OG011	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.
OG012	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.
OG013	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.

Units	Counts
Participants	OG00039 OG00149 OG00231 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Primary

Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)

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

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003

Primary

Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events

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.

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Number of Participants With Leukemia

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Primary

Number of Participants With Myelodysplastic Syndrome

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Primary

Number of Participants With Aplastic Anemia

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Primary

Number of Participants With Primary Bone Cancer

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Primary

Number of Participants With Any Other New Primary Malignancy

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Primary

Number of Participants With Bone Fractures

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Primary

Number of Participants With Bone-associated Events

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Primary

Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group

Primary

Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy

Posted

Number

Participants

Up to 7 years

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	From Study 15396 Radium-223 Dichloride+Abi/Pred Group	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.	24	39	3	39	2	39
EG001	From Study 15396 Placebo+Abi/Pred Group	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.	32	49	4	49	6	49
EG002	From Study 16216 Radium-223 Dichloride Group	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.	25	31	4	31	0	31
EG003	From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group	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.	11	14	1	14	3	14
EG004	From Study 16298 Placebo + Hormonal Therapy Group	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.	5	9	1	9	3	9
EG005	From Study 16506 Radium-223 Dichloride Group	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.	5	5	0	5	0	5
EG006	From Study 16507 Radium-223 Dichloride Treatment A Group	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.	8	11	2	11	1	11
EG007	From Study 16507 Radium-223 Dichloride Treatment B Group	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.	5	9	3	9	1	9
EG008	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.	7	11	3	11	3	11
EG009	From Study 16544 Radium-223 Dichloride+Abi/Pred Group	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.	3	9	0	9	3	9
EG010	From Study 16544 Radium-223 Dichloride+Enzalutamide Group	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.	3	4	1	4	1	4
EG011	From Study 16544 Radium-223 Dichloride Group	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.	1	3	0	3	1	3
EG012	From Study 17096 Radium-223 Dichloride + EXE/EVE Group	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.	25	33	4	33	8	33
EG013	From Study 17096 Placebo + EXE/EVEgroup	Safety FU from feeder study 17096. Participants received placebo matched to radium-223 dichloride along with exemestane (EXE) + everolimus (EVE) once daily.	19	28	6	28	3	28

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG0030 events0 affected14 at risk EG004
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected49 at risk EG0020 events0 affected31 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0021 events1 affected31 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected39 at risk EG0013 events2 affected49 at risk EG0020 events0 affected31 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0021 events1 affected31 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0021 events1 affected31 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0021 events1 affected31 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected49 at risk EG0020 events0 affected31 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG0030 events0 affected14 at risk EG0040 events0 affected9 at risk EG0050 events0 affected5 at risk EG0060 events0 affected11 at risk EG0070 events0 affected9 at risk EG0080 events0 affected11 at risk EG0090 events0 affected9 at risk EG0100 events0 affected4 at risk EG0110 events0 affected3 at risk EG0121 events1 affected33 at risk EG0130 events0 affected28 at risk
Cataract	Eye disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected49 at risk EG0020 events0 affected31 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Neutrophil count decreased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Platelet count decreased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected49 at risk EG0020 events0 affected31 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0012 events1 affected49 at risk EG0020 events0 affected31 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected39 at risk EG0013 events3 affected49 at risk EG0020 events0 affected31 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected49 at risk EG0020 events0 affected31 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Genital haemorrhage	Reproductive system and breast disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003
Device failure	Product Issues	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected49 at risk EG0020 events0 affected31 at risk EG003

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D011634	Public Health
D004778	Environment and Public Health