Radium-223 Dichloride and Abiraterone Acetate Compared to... | NCT02043678

NCT02043678

ID	Type	Description	Link
2013-003438-33	EudraCT Number

Status Module

Name	Class
Janssen Research & Development, LLC	INDUSTRY

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
Radium-223 dichloride + Abi/Pred	Experimental	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met)	Drug: Radium-223 dichloride (Xofigo, BAY88-8223) Drug: Abiraterone Drug: Prednisone/Prednisolone
Placebo + Abi/Pred	Placebo Comparator	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met)	Drug: Matching placebo (normal saline) Drug: Abiraterone Drug: Prednisone/Prednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radium-223 dichloride (Xofigo, BAY88-8223)	Drug	50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of NIST update) body weight, intravenous injection (IV-slow bolus), every 4 weeks for 6 cycles

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptomatic Skeletal Event Free Survival (SSE-FS)	SSE-FS was defined as time (months) from randomization to the earliest of onset date of skeletal symptoms treated with external beam radiotherapy (EBRT), onset date of pathological bone fracture, onset date of spinal cord compression, procedure date of tumor-related orthopedic surgery, or death from any cause. Participants who died without prior SSE and ≥ 13 weeks after the last SSE assessment are censored at the last SSE assessment date. Participants alive at the survival cut-off date are censored at the last date known to be alive. Participants with multiple events are only counted for the category in which the first event occurred. If multiple SSE (component events) occur on the same date for 1 participant, the participant is only counted into 1 category in the order of: spinal cord compression > bone fracture > orthopedic surgery > EBRT.	From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time (months) from the date of randomization to the date of death due to any cause. Participants alive at the survival cut-off date were censored at the last date known to be alive.	From randomization until death from any cause, up to 67 months
Radiological Progression Free Survival (rPFS)

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

Citations

PubMed Identifier	Type	Citation	Retractions
30738780	Result	Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nole F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6.
32404868

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	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 8, 2023	Jan 30, 2025

Arm/Group Information

ID	Title	Description
BG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
BG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
BG002	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, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00022.3(20.4 to 24.8) OG00126.0(21.8 to 28.3)

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		Cox Proportional Hazards Model		0.2636		Hazard Ratio (HR)	1.122			2-Sided	95	0.917	1.374					Superiority

Secondary

Overall Survival (OS)

OS was defined as the time (months) from the date of randomization to the date of death due to any cause. Participants alive at the survival cut-off date were censored at the last date known to be alive.

ITT analysis set (included all randomized participants)

Posted

Median

95% Confidence Interval

Months

From randomization until death from any cause, up to 67 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

Secondary

Radiological Progression Free Survival (rPFS)

rPFS was defined as the time (months) from the date of randomization to the date of confirmed radiological progression or death (if death occurred before progression) based on independent assessment.

ITT analysis set (included all randomized participants)

Posted

Median

95% Confidence Interval

Months

From randomization until the date of confirmed radiological progression or death, up to 47 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

Secondary

Time to Pain Progression

Time to pain progression was defined as the interval from randomization to the first date a participant experienced pain progression assessed by Brief Pain Inventory-Short Form and defined as: an increase of 2 or more points in the average worst pain score (WPS) from baseline observed at 2 consecutive evaluations ≥4 weeks apart or initiation of short- or long-acting opioid use for pain for participants with WPS 0 at baseline; an increase of 2 or more points in the average WPS from baseline observed at 2 consecutive evaluations ≥4 weeks apart and an average WPS of ≥4 OR initiation of short- or long-acting opioid use for pain for participants with WPS 1 to 3 at baseline. Participants without pain progression at end of study are censored at the last date known to have not progressed: last evaluation date for pain scores or last visit when recorded opiate use, whichever is last. Participants with no on-study assessment or no baseline assessment are censored at the date of randomization.

ITT analysis set (included all randomized participants)

Posted

Median

95% Confidence Interval

Months

From randomization until the date of pain progression based on pain score, up to 47 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).

Secondary

Time to Cytotoxic Chemotherapy

Time to cytotoxic chemotherapy is time (months) from randomization to the earliest date of the first cytotoxic chemotherapy. Participants who have not started cytotoxic chemotherapy during the study were censored at the last assessment date.

ITT analysis set (included all randomized participants)

Posted

Median

95% Confidence Interval

Months

From randomization until the date of first cytotoxic chemotherapy, up to 47 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

Secondary

Time to Opiate Use for Cancer Pain

Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use.

ITT analysis set excluding participants who had opiate use at baseline

Posted

Median

95% Confidence Interval

Months

From randomization until the date of opiate use, up to 47 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

Units

Secondary

Number of Participants With Treatment-emergent Adverse Events

An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was life-threatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. A treatment-emergent AEs (TEAEs) or serious TEAEs was defined as any event that started on or after the first dose of the study treatment and during the treatment period and was not a continuation of a pretreatment event or started before the first dose and worsened after the first dose or the treatment period. Drug-related TEAEs or serious TEAEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

From start of study treatment until the end of the treatment period, up to 110 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).

Secondary

Number of Participants With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity

An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. A treatment-emergent AEs (TEAEs) or serious TEAEs was defined as any event that started on or after the first dose of the study treatment and during the treatment period and was not a continuation of a pretreatment event or started before the first dose and worsened after the first dose or the treatment period. Radium-223/placebo-related TEAEs or serious TEAEs were those with "reasonable causal relationship" to radium-223 or placebo decided by the investigators.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

From start of study treatment until the end of the treatment period, up to 110 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).

Secondary

Number of Participants With Any Treatment-emergent Additional Primary Malignancies

Treatment-emergent additional primary malignancies were adverse events identified as additional primary malignancies that occurred after start of study treatment until the end of the treatment period.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

From start of study treatment until the end of the treatment period, up to 110 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

Secondary

Number of Participants With Treatment-emergent Bone Fractures

Treatment-emergent fractures were adverse events identified as fractures that occurred after start of study treatment until the end of the treatment period. All bone fractures and bone-associated events (e.g., osteoporosis) were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

From start of study treatment until the end of the treatment period, up to 110 months

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

Secondary

Number of Participants With Post-treatment Adverse Events

An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred

Secondary

Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity

An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred

Secondary

Number of Participants With Post-treatment Additional Primary Malignancies

Post-treatment additional primary malignancies were adverse events identified as additional primary malignancies that started after the treatment period.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

Secondary

Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders

Post-treatment blood and lymphatic system disorders were adverse events identified as blood and lymphatic system disorders that occurred after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

Secondary

Number of Participants With Post-treatment Bone Fractures

Post-treatment fractures were adverse events identified as fractures that occured after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study. All bone fractures and bone-associated events (e.g., osteoporosis), were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment.

Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug

Posted

Count of Participants

Participants

After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up

ID	Title	Description
OG000	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
OG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).

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	Radium-223 Dichloride + Abi/Pred	Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).	287	392	193	392	368	392
EG001	Placebo + Abi/Pred	Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).	290	394	191	394	376	394

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG00019 events9 affected392 at risk EG0015 events4 affected394 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0016 events6 affected394 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0006 events1 affected392 at risk EG0010 events0 affected394 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected394 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected394 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0008 events3 affected392 at risk EG0010 events0 affected394 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0005 events4 affected392 at risk EG0014 events4 affected394 at risk
Angina pectoris	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Arrhythmia	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0013 events2 affected394 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0005 events4 affected392 at risk EG0019 events8 affected394 at risk
Atrial flutter	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0011 events1 affected394 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0010 events0 affected394 at risk
Cardiac arrest	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Cardiac failure	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0016 events3 affected394 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected394 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Myocardial infarction	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0004 events3 affected392 at risk EG0011 events1 affected394 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0012 events1 affected394 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0010 events0 affected394 at risk
Cardiac disorder	Cardiac disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Inborn error of metabolism	Congenital, familial and genetic disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Primary adrenal insufficiency	Endocrine disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Cataract	Eye disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected394 at risk
Retinal artery occlusion	Eye disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Constipation	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0014 events4 affected394 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected394 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Ileus	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Nausea	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Vomiting	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0012 events2 affected394 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0014 events2 affected394 at risk
Anal prolapse	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Overflow diarrhoea	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Asthenia	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0016 events4 affected394 at risk
Condition aggravated	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0010 events0 affected394 at risk
Death	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Fatigue	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0012 events2 affected394 at risk
Gait disturbance	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Influenza like illness	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Malaise	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Oedema peripheral	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected394 at risk
Pain	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Pyrexia	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0005 events5 affected392 at risk EG0014 events4 affected394 at risk
Sudden death	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected394 at risk
Peripheral swelling	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
General physical health deterioration	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG00013 events9 affected392 at risk EG00119 events13 affected394 at risk
Physical deconditioning	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Non-cardiac chest pain	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected394 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected394 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected394 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Acute sinusitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Appendicitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Bacteraemia	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Bronchitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Cellulitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0012 events2 affected394 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Dengue fever	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Diverticulitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Encephalitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Erysipelas	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Gastroenteritis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0012 events2 affected394 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Influenza	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected394 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0011 events1 affected394 at risk
Lyme disease	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Osteomyelitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Pneumonia	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG00015 events12 affected392 at risk EG00120 events16 affected394 at risk
Pneumonia aspiration	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Sepsis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0004 events2 affected392 at risk EG0017 events4 affected394 at risk
Septic shock	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Sinusitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected394 at risk
Skin infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0016 events5 affected394 at risk
Urinary tract infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG00021 events18 affected392 at risk EG00113 events11 affected394 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0013 events2 affected394 at risk
Wound infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0003 events1 affected392 at risk EG0011 events1 affected394 at risk
Urosepsis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG00112 events6 affected394 at risk
Tooth infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Acute endocarditis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected394 at risk
Groin infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Pulmonary sepsis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0004 events2 affected392 at risk EG0011 events1 affected394 at risk
Arthritis bacterial	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Staphylococcal infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Arthritis infective	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Respiratory tract infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Neurocryptococcosis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Large intestine infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0006 events2 affected392 at risk EG0014 events4 affected394 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected394 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0012 events2 affected394 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected394 at risk
Ilium fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected394 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events1 affected394 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0004 events2 affected392 at risk EG0010 events0 affected394 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0013 events3 affected394 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Pseudophakic bullous keratopathy	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Alanine aminotransferase increased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0006 events2 affected392 at risk EG0011 events1 affected394 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0005 events2 affected392 at risk EG0011 events1 affected394 at risk
Blood bilirubin increased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Platelet count decreased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0013 events1 affected394 at risk
Weight decreased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Influenza A virus test positive	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0004 events4 affected392 at risk EG0012 events2 affected394 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected394 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0013 events1 affected394 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0013 events2 affected394 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0013 events1 affected394 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG00111 events2 affected394 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0010 events0 affected394 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0004 events4 affected392 at risk EG0012 events2 affected394 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0007 events6 affected392 at risk EG00112 events11 affected394 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0008 events7 affected392 at risk EG0018 events5 affected394 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0004 events3 affected392 at risk EG0013 events2 affected394 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events1 affected394 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected394 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected394 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00014 events9 affected392 at risk EG0013 events1 affected394 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00015 events10 affected392 at risk EG0014 events4 affected394 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Sacral pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0013 events3 affected394 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected394 at risk
Spinal instability	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Jaw fistula	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0003 events1 affected392 at risk EG0011 events1 affected394 at risk
Anaplastic thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0008 events3 affected392 at risk EG00113 events6 affected394 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0013 events2 affected394 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0016 events2 affected394 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected394 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0011 events1 affected394 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0013 events1 affected394 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected394 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Nasal sinus cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events1 affected394 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0009 events8 affected392 at risk EG00124 events8 affected394 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0010 events0 affected394 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Non-systematic Assessment	EG0002 events1 affected392 at risk EG0010 events0 affected394 at risk
Alexia	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected394 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected394 at risk
Dizziness	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0010 events0 affected394 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Loss of consciousness	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Monoplegia	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Neuralgia	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Paraparesis	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Presyncope	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Radiculopathy	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Sciatica	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0010 events0 affected394 at risk
Seizure	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0012 events2 affected394 at risk
Spinal cord compression	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0007 events7 affected392 at risk EG0019 events9 affected394 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Syncope	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0012 events2 affected394 at risk
Transient global amnesia	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0012 events2 affected394 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Spinal epidural haematoma	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Cognitive disorder	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Vascular dementia	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events1 affected392 at risk EG0010 events0 affected394 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events3 affected392 at risk EG0010 events0 affected394 at risk
Parkinson's disease	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Confusional state	Psychiatric disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Delirium	Psychiatric disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0012 events2 affected394 at risk
Depression	Psychiatric disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Adjustment disorder	Psychiatric disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Dysuria	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Haematuria	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0006 events5 affected392 at risk EG0015 events4 affected394 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0014 events4 affected394 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0010 events0 affected394 at risk
Renal colic	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0013 events2 affected394 at risk
Renal failure	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Urinary retention	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0005 events4 affected392 at risk EG0013 events3 affected394 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events1 affected392 at risk EG0010 events0 affected394 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0017 events2 affected394 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0013 events2 affected394 at risk
Prostatism	Reproductive system and breast disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0012 events1 affected394 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0015 events4 affected394 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events1 affected392 at risk EG0010 events0 affected394 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk
Pneumonitis aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events1 affected394 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0007 events6 affected392 at risk EG0012 events2 affected394 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0003 events2 affected392 at risk EG0011 events1 affected394 at risk
Lower respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Aortic dissection	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0013 events2 affected394 at risk
Aortic stenosis	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0011 events1 affected394 at risk
Circulatory collapse	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0010 events0 affected394 at risk
Hypertension	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0013 events2 affected394 at risk
Hypotension	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0002 events2 affected392 at risk EG0011 events1 affected394 at risk
Lymphoedema	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0000 events0 affected392 at risk EG0012 events2 affected394 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0005 events2 affected392 at risk EG0010 events0 affected394 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0004 events1 affected392 at risk EG0010 events0 affected394 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG0001 events1 affected392 at risk EG0011 events1 affected394 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (26.1)	Non-systematic Assessment	EG000135 events64 affected392 at risk EG001129 events62 affected394 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG00024 events23 affected392 at risk EG00120 events17 affected394 at risk
Constipation	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG00084 events71 affected392 at risk EG001102 events83 affected394 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG000111 events71 affected392 at risk EG001102 events71 affected394 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG00023 events20 affected392 at risk EG00117 events16 affected394 at risk
Nausea	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG00092 events76 affected392 at risk EG00177 events69 affected394 at risk
Vomiting	Gastrointestinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG00049 events41 affected392 at risk EG00148 events42 affected394 at risk
Asthenia	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG00050 events39 affected392 at risk EG00161 events44 affected394 at risk
Chest pain	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG00022 events20 affected392 at risk EG00125 events19 affected394 at risk
Fatigue	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG000152 events106 affected392 at risk EG001140 events97 affected394 at risk
Influenza like illness	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG00019 events15 affected392 at risk EG00124 events20 affected394 at risk
Oedema peripheral	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG00083 events61 affected392 at risk EG00181 events68 affected394 at risk
Pyrexia	General disorders	MedDRA (26.1)	Non-systematic Assessment	EG00035 events30 affected392 at risk EG00150 events34 affected394 at risk
Influenza	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG00023 events22 affected392 at risk EG00122 events14 affected394 at risk
Nasopharyngitis	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG00040 events31 affected392 at risk EG00154 events39 affected394 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG00042 events29 affected392 at risk EG00147 events35 affected394 at risk
Urinary tract infection	Infections and infestations	MedDRA (26.1)	Non-systematic Assessment	EG00055 events40 affected392 at risk EG00141 events34 affected394 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG00093 events61 affected392 at risk EG00178 events52 affected394 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG00037 events22 affected392 at risk EG00139 events17 affected394 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (26.1)	Non-systematic Assessment	EG00038 events28 affected392 at risk EG00141 events33 affected394 at risk
Alanine aminotransferase increased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG000180 events69 affected392 at risk EG001151 events61 affected394 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG000127 events61 affected392 at risk EG001106 events55 affected394 at risk
Weight decreased	Investigations	MedDRA (26.1)	Non-systematic Assessment	EG00037 events23 affected392 at risk EG00139 events25 affected394 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG00018 events12 affected392 at risk EG00150 events23 affected394 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG00081 events43 affected392 at risk EG00187 events45 affected394 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (26.1)	Non-systematic Assessment	EG00086 events68 affected392 at risk EG00158 events54 affected394 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG000170 events106 affected392 at risk EG001197 events104 affected394 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG000258 events154 affected392 at risk EG001214 events140 affected394 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG000103 events72 affected392 at risk EG001101 events76 affected394 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00034 events28 affected392 at risk EG00134 events30 affected394 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00040 events26 affected392 at risk EG00151 events37 affected394 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00020 events16 affected392 at risk EG00124 events22 affected394 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00029 events25 affected392 at risk EG00127 events24 affected394 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00019 events18 affected392 at risk EG00132 events26 affected394 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00028 events27 affected392 at risk EG0011 events1 affected394 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00075 events26 affected392 at risk EG0013 events3 affected394 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00075 events53 affected392 at risk EG00180 events59 affected394 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00073 events49 affected392 at risk EG00143 events28 affected394 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00043 events30 affected392 at risk EG00140 events32 affected394 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Non-systematic Assessment	EG00036 events31 affected392 at risk EG00134 events27 affected394 at risk
Dizziness	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG00054 events45 affected392 at risk EG00144 events37 affected394 at risk
Headache	Nervous system disorders	MedDRA (26.1)	Non-systematic Assessment	EG00046 events31 affected392 at risk EG00138 events31 affected394 at risk
Insomnia	Psychiatric disorders	MedDRA (26.1)	Non-systematic Assessment	EG00037 events34 affected392 at risk EG00127 events26 affected394 at risk
Haematuria	Renal and urinary disorders	MedDRA (26.1)	Non-systematic Assessment	EG00045 events32 affected392 at risk EG00129 events21 affected394 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (26.1)	Non-systematic Assessment	EG00016 events12 affected392 at risk EG00131 events21 affected394 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG00042 events36 affected392 at risk EG00153 events42 affected394 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Non-systematic Assessment	EG00030 events21 affected392 at risk EG00136 events32 affected394 at risk
Hypertension	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG000168 events62 affected392 at risk EG001221 events83 affected394 at risk
Hot flush	Vascular disorders	MedDRA (26.1)	Non-systematic Assessment	EG00026 events24 affected392 at risk EG00153 events51 affected394 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
C581106	radium Ra 223 dichloride
D000077330	Saline Solution
C089740	abiraterone
D011241	Prednisone
D011239	Prednisolone

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011246	Pregnadienetriols