Neoplasm Metastasis / Bone and Bones
Conditions
Brief summary
Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo.
Detailed description
This long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials). The primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.
Interventions
OTHERData Collection
No study treatment will be provided in this long term follow up study.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial
Exclusion criteria
* Not applicable to this follow up study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Up to 7 years | 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. |
| Number of Participants With Aplastic Anemia | Up to 7 years | — |
| Number of Participants With Primary Bone Cancer | Up to 7 years | — |
| Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Up to 7 years | Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE) |
| Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 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. |
| Number of Participants With Leukemia | Up to 7 years | — |
| Number of Participants With Myelodysplastic Syndrome | Up to 7 years | — |
| Number of Participants With Any Other New Primary Malignancy | Up to 7 years | — |
| Number of Participants With Bone Fractures | Up to 7 years | — |
| Number of Participants With Bone-associated Events | Up to 7 years | — |
| Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | Up to 7 years | — |
| Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | Up to 7 years | — |
Countries
Australia, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Norway, Poland, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| 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. | 49 |
| 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. | 31 |
| 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. | 14 |
| 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. | 9 |
| 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. | 5 |
| 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. | 11 |
| 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. | 9 |
| 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. | 11 |
| 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. | 9 |
| 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. | 4 |
| 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. | 3 |
| 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. | 33 |
| 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. | 28 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 24 | 32 | 25 | 11 | 5 | 5 | 8 | 5 | 7 | 3 | 3 | 1 | 25 | 19 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Missing | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 | 0 | 1 | 0 | 1 | 2 | 2 | 3 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | From Study 15396 Placebo+Abi/Pred Group | From Study 16216 Radium-223 Dichloride Group | From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | From Study 15396 Radium-223 Dichloride+Abi/Pred Group | From Study 16298 Placebo + Hormonal Therapy Group | From Study 16506 Radium-223 Dichloride Group | From Study 16507 Radium-223 Dichloride Treatment A Group | From Study 16507 Radium-223 Dichloride Treatment B Group | From Study 16507 Radium-223 Dichloride Treatment C Group | From Study 16544 Radium-223 Dichloride+Abi/Pred Group | From Study 16544 Radium-223 Dichloride+Enzalutamide Group | From Study 16544 Radium-223 Dichloride Group | From Study 17096 Radium-223 Dichloride + EXE/EVE Group | From Study 17096 Placebo + EXE/EVEgroup |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 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 | 0 Participants |
| Age, Categorical >=65 years | 174 Participants | 46 Participants | 28 Participants | 5 Participants | 33 Participants | 4 Participants | 3 Participants | 10 Participants | 7 Participants | 6 Participants | 8 Participants | 3 Participants | 2 Participants | 7 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 3 Participants | 3 Participants | 9 Participants | 6 Participants | 5 Participants | 2 Participants | 1 Participants | 2 Participants | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 26 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 4 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 232 Participants | 41 Participants | 31 Participants | 13 Participants | 32 Participants | 9 Participants | 5 Participants | 11 Participants | 9 Participants | 10 Participants | 8 Participants | 3 Participants | 3 Participants | 30 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 4 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 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 | 0 Participants |
| Race (NIH/OMB) Asian | 53 Participants | 13 Participants | 0 Participants | 4 Participants | 6 Participants | 2 Participants | 0 Participants | 4 Participants | 5 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 6 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 183 Participants | 30 Participants | 31 Participants | 9 Participants | 29 Participants | 7 Participants | 5 Participants | 7 Participants | 4 Participants | 7 Participants | 7 Participants | 3 Participants | 3 Participants | 21 Participants | 20 Participants |
| Sex: Female, Male Female | 84 Participants | 0 Participants | 0 Participants | 14 Participants | 0 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 33 Participants | 28 Participants |
| Sex: Female, Male Male | 171 Participants | 49 Participants | 31 Participants | 0 Participants | 39 Participants | 0 Participants | 5 Participants | 11 Participants | 9 Participants | 11 Participants | 9 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 24 / 39 | 32 / 49 | 25 / 31 | 11 / 14 | 5 / 9 | 5 / 5 | 8 / 11 | 5 / 9 | 7 / 11 | 3 / 9 | 3 / 4 | 1 / 3 | 25 / 33 | 19 / 28 |
| other Total, other adverse events | 2 / 39 | 6 / 49 | 0 / 31 | 3 / 14 | 3 / 9 | 0 / 5 | 1 / 11 | 1 / 9 | 3 / 11 | 3 / 9 | 1 / 4 | 1 / 3 | 8 / 33 | 3 / 28 |
| serious Total, serious adverse events | 3 / 39 | 4 / 49 | 4 / 31 | 1 / 14 | 1 / 9 | 0 / 5 | 2 / 11 | 3 / 9 | 3 / 11 | 0 / 9 | 1 / 4 | 0 / 3 | 4 / 33 | 6 / 28 |
Outcome results
Primary
Number of Participants With Any Other New Primary Malignancy
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Any Other New Primary Malignancy | 1 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Any Other New Primary Malignancy | 1 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Any Other New Primary Malignancy | 1 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Any Other New Primary Malignancy | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Any Other New Primary Malignancy | 0 Participants |
Primary
Number of Participants With Aplastic Anemia
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Aplastic Anemia | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Aplastic Anemia | 1 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Aplastic Anemia | 0 Participants |
Primary
Number of Participants With Bone-associated Events
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Bone-associated Events | 1 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Bone-associated Events | 2 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Bone-associated Events | 1 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Bone-associated Events | 2 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Bone-associated Events | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Bone-associated Events | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Bone-associated Events | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Bone-associated Events | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Bone-associated Events | 4 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Bone-associated Events | 2 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Bone-associated Events | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Bone-associated Events | 1 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Bone-associated Events | 3 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Bone-associated Events | 0 Participants |
Primary
Number of Participants With Bone Fractures
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Bone Fractures | 3 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Bone Fractures | 6 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Bone Fractures | 1 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Bone Fractures | 1 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Bone Fractures | 3 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Bone Fractures | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Bone Fractures | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Bone Fractures | 2 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Bone Fractures | 3 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Bone Fractures | 1 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Bone Fractures | 2 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Bone Fractures | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Bone Fractures | 6 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Bone Fractures | 7 Participants |
Primary
Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 1 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 1 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
Primary
Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy | 2 Participants |
Primary
Number of Participants With Leukemia
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Leukemia | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Leukemia | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Leukemia | 1 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Leukemia | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Leukemia | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Leukemia | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Leukemia | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Leukemia | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Leukemia | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Leukemia | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Leukemia | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Leukemia | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Leukemia | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Leukemia | 0 Participants |
Primary
Number of Participants With Myelodysplastic Syndrome
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Myelodysplastic Syndrome | 0 Participants |
Primary
Number of Participants With Primary Bone Cancer
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Primary Bone Cancer | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Primary Bone Cancer | 0 Participants |
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.
Time frame: Up to 7 years
Population: SAF-LTF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 1 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 1 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 3 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 1 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 3 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | 0 Participants |
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.
Time frame: Up to 7 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 1 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 2 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 1 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events | 0 Participants |
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)
Time frame: Up to 7 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 15396 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 1 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 15396 Placebo+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 16216 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 1 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16298 Radium-223 Dichloride+Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16298 Placebo + Hormonal Therapy Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16506 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 1 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment A Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment B Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 2 Participants |
| From Study 16507 Radium-223 Dichloride Treatment C Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 1 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Abi/Pred Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16544 Radium-223 Dichloride+Enzalutamide Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 1 Participants |
| From Study 16544 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 16544 Radium-223 Dichloride Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 2 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 1 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 17096 Radium-223 Dichloride + EXE/EVE Group | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 5 (death) | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 1 | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 4 | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 2 | 0 Participants |
| From Study 17096 Placebo + EXE/EVEgroup | Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) | Grade 3 | 0 Participants |