Study of Radium-223 Dichloride Versus Placebo and Hormona... | NCT02258464

ID	Type	Description	Link
2014-002113-39	EudraCT Number

Label	Type	Description	Intervention Names
Radium 223 dichloride	Experimental	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks	Drug: Radium-223 dichloride (Xofigo, BAY88-8223) Other: Background hormonal therapy
Placebo	Placebo Comparator	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks	Drug: Placebo (saline) Other: Background hormonal therapy

Name	Type	Description	Arm Group Labels	Other Names
Radium-223 dichloride (Xofigo, BAY88-8223)	Drug	Up to 6 cycles of radium-223 dichloride 50kBq/kg body (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update)

Measure	Description	Time Frame
Symptomatic Skeletal Event Free Survival (SSE-FS)	Time from date of randomization to occurrence of one of the following, whichever happened earlier: 1) an on study SSE, which was defined as the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms, the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral), the occurrence of spinal cord compression, a tumor related orthopedic surgical intervention; or 2) death from any cause	Up to approximately 51 months

Measure	Description	Time Frame
Overall Survival	Time from randomization to death from any cause	Up to approximately 51 months
Time to Opiate Use for Cancer Pain	Interval from the date of randomization to the date of opiate use

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.
Women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
Documentation of menopausal status: post menopausal or premenopausal subjects are eligible.
Subjects with bone dominant disease with at least 2 skeletal metastases identified at baseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI). Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymph nodes)and/or visceral metastases is allowed.
Measurable or non-measurable disease (but radiologically evaluable) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Subjects must have received at least one line of hormonal therapy in the metastatic setting
Subjects who are eligible for further standard of care endocrine treatment.
Subjects enrolled in the current study must start treatment with the single hormone agent either within 15 days prior to randomization or after randomization (before or simultaneously to the first injection of Ra-223/placebo).
Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
Subjects must be on therapy with bisphosphonate and denosumab. and are required to have been on such therapy for at least 1 month before start of study treatment.
Adequate hematological, liver and kidney function.

Exclusion Criteria:

Subjects with Inflammatory breast cancer.
Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable.
Subjects with known or history of brain metastases or leptomeningeal disease: subjects with neurological symptoms must undergo a contrast CT scan or MRI of the brain within 28 days prior to randomization to exclude active brain metastasis. Imaging of the central nervous system (CNS) is otherwise not required.
Known presence of osteonecrosis of jaw.
Patients with immediately life-threatening visceral disease, for whom chemotherapy is the preferred treatment option.
Lymphangitic carcinomatosis.
Patients with ascites requiring paracentesis within 2 weeks prior to study entry (signature of informed consent) and during the screening period.

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Bakersfield	California	93309	United States

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

ID	Title	Description
FG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Aug 12, 2019	Jul 1, 2020

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

Symptomatic Skeletal Event Free Survival (SSE-FS)

Time from date of randomization to occurrence of one of the following, whichever happened earlier: 1) an on study SSE, which was defined as the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms, the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral), the occurrence of spinal cord compression, a tumor related orthopedic surgical intervention; or 2) death from any cause

Intent to treat analysis set: all randomized participants

Posted

Median

80% Confidence Interval

months

Up to approximately 51 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Units	Counts
Participants	OG00049 OG00150

Title

Denominators

Categories

Title	Measurements
	OG00030.1± 21.8(21.8 to 43.0) OG00118.4± 9.1(9.1 to 28.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis that both treatment groups have the same SSE-FS distribution will be tested against the alternative hypothesis that the distribution of SSE-FS time in radium-223 dichloride is different from the placebo group	Log Rank		0.3339	The SSE-FS was compared using a stratified log-rank test with a 2-sided alpha of 0.2	Hazard Ratio (Radium 223/Placebo)	0.745			2-Sided	80	0.504	1.102					Other

Secondary

Overall Survival

Time from randomization to death from any cause

Intent to treat analysis set: all randomized participants

Posted

Median

80% Confidence Interval

months

Up to approximately 51 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Units	Counts
Participants	OG000

Secondary

Time to Opiate Use for Cancer Pain

Interval from the date of randomization to the date of opiate use

Safety analysis set: all randomized participants who received at least one study drug administration (radium 223 dichloride or placebo)

Posted

Median

80% Confidence Interval

months

Up to approximately 51 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Units	Counts
Participants	OG000

Secondary

Time to Pain Progression

Time from randomization to the first date a participants (only in participants with baseline WPS ≤8) experiences pain progression based on worst pain score (WPS) ranging from 0 to 10 and analgesic use. Pain progression is defined as an increase of 2 or more points in the "Worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥4 weeks apart or an increase in pain management (IPM) with respect to baseline, whichever occurs first

Safety analysis set: all randomized participants who received at least one study drug administration (radium 223 dichloride or placebo)

Posted

Median

80% Confidence Interval

months

Up to approximately 51 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Secondary

Pain Improvement Rate

The percentage of participants (baseline WPS>=2) with confirmed pain improvement at any time point. Confirmed pain improvement is defined as a 2 point decrease in worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart

Participants in safety analysis set taken into account for this endpoint analysis

Posted

Number

80% Confidence Interval

percentage of participants analyzed

Up to approximately 51 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Units	Counts
Participants

Secondary

Time to Cytotoxic Chemotherapy

Time from the date of randomization to the date of the first cytotoxic chemotherapy

Intent to treat analysis set: all randomized participants

Posted

Median

80% Confidence Interval

months

Up to approximately 51 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Units	Counts
Participants	OG000

Secondary

Radiological Progression-free Survival (rPFS)

Time from the date of randomization to the date of first radiological progression or death (if death occurs before progression)

Intent to treat analysis set: all randomized participants

Posted

Median

80% Confidence Interval

months

Up to approximately 51 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Units	Counts
Participants	OG000

Secondary

Number of Participants With Treatment-emergent Adverse Events

Any event arising or worsening after the start of study drug administration until 30 days after the last study medication intake

Safety analysis set: all randomized subjects who received at least one dose of study medication (radium 223 dichloride or placebo)

Posted

Count of Participants

Participants

Up to approximately 7 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Units	Counts
Participants

Secondary

Number of Participants With Post-treatment Adverse Events Including Additional Malignancies and Chemotherapy Related Adverse Events

AEs related to the study drug, all occurrences of additional malignancies, febrile neutropenia and hemorrhage in subjects receiving chemotherapy, bone fractures and bone associated events (regardless of severity and relationship to study drug), and some symptoms needed for the characterization of an symptomatic skeletal event

Safety analysis set: all randomized subjects who received at least one dose of study medication (radium 223 dichloride or placebo)

Posted

Count of Participants

Participants

From 30 days after the last dose of study treatment until the end of study, assessed up to approximately 44 months

ID	Title	Description
OG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
OG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0012 events1 affected49 at risk
Chest pain	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Bacteraemia	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0012 events1 affected49 at risk
Sinusitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Urosepsis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0012 events1 affected49 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Platelet count decreased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events1 affected48 at risk EG0013 events3 affected49 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0002 events1 affected48 at risk EG0011 events1 affected49 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Nerve compression	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Seizure	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Syncope	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected49 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected49 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected49 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events3 affected48 at risk EG0017 events3 affected49 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0006 events3 affected48 at risk EG0010 events0 affected49 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (22.0)	Non-systematic Assessment	EG00012 events5 affected48 at risk EG0010 events0 affected49 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0006 events5 affected48 at risk EG0013 events2 affected49 at risk
Constipation	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events4 affected48 at risk EG0014 events4 affected49 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00015 events10 affected48 at risk EG00110 events7 affected49 at risk
Nausea	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG00018 events12 affected48 at risk EG00113 events9 affected49 at risk
Vomiting	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0007 events7 affected48 at risk EG00111 events7 affected49 at risk
Fatigue	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG00015 events12 affected48 at risk EG00110 events9 affected49 at risk
Influenza like illness	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events3 affected48 at risk EG0011 events1 affected49 at risk
Oedema peripheral	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events3 affected48 at risk EG0011 events1 affected49 at risk
Pain	General disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0013 events3 affected49 at risk
Nasopharyngitis	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0003 events3 affected48 at risk EG0013 events3 affected49 at risk
Urinary tract infection	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0002 events2 affected48 at risk EG0015 events4 affected49 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0003 events2 affected48 at risk EG0016 events4 affected49 at risk
Weight decreased	Investigations	MedDRA (22.0)	Non-systematic Assessment	EG0005 events3 affected48 at risk EG0013 events3 affected49 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events3 affected48 at risk EG0015 events5 affected49 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00014 events10 affected48 at risk EG00117 events11 affected49 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00018 events14 affected48 at risk EG00110 events7 affected49 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00012 events11 affected48 at risk EG00115 events9 affected49 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG00010 events6 affected48 at risk EG0014 events4 affected49 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events4 affected48 at risk EG0012 events2 affected49 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events4 affected48 at risk EG0011 events1 affected49 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0008 events6 affected48 at risk EG0019 events7 affected49 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0008 events6 affected48 at risk EG0018 events7 affected49 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events4 affected48 at risk EG0013 events2 affected49 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected48 at risk EG0017 events4 affected49 at risk
Dizziness	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0003 events2 affected48 at risk EG0013 events3 affected49 at risk
Headache	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG00019 events13 affected48 at risk EG0014 events4 affected49 at risk
Paraesthesia	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected48 at risk EG0015 events4 affected49 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected48 at risk EG0014 events4 affected49 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0004 events3 affected48 at risk EG0010 events0 affected49 at risk
Hypertension	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0005 events3 affected48 at risk EG0015 events3 affected49 at risk
Hot flush	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected48 at risk EG0013 events3 affected49 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
C581106	radium Ra 223 dichloride
D012965	Sodium Chloride

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Title	Description
BG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
BG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Radium 223 Dichloride	Participants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks	18	48	4	48	43	48
EG001	Placebo	Participants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks	18	49	14	49	44	49