A Study of Niraparib in Combination With Abiraterone Acet... | NCT03748641

NCT03748641

ID	Type	Description
64091742PCR3001	Other Identifier	Janssen Research & Development, LLC
2017-003364-12	EudraCT Number
2023-503254-12-00	Registry Identifier	EUCT number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
Cohort 1: Participants with mCRPC and HRR Gene Alteration	Experimental	Participants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.	Drug: Niraparib Drug: Abiraterone Acetate Drug: Prednisone Drug: Placebo
Cohort 2: Participants with mCRPC and No HRR Gene Alteration	Experimental	Participants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.	Drug: Niraparib Drug: Abiraterone Acetate Drug: Prednisone Drug: Placebo
Cohort 3 (Open-label): Participants with mCRPC	Experimental	Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Niraparib	Drug	Participants will receive niraparib 200 mg capsules or tablets once daily.	Cohort 1: Participants with mCRPC and HRR Gene Alteration Cohort 2: Participants with mCRPC and No HRR Gene Alteration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)	As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; (2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >=2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.	Up to 32 months
Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)	As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan >=6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >=2 new lesions means no progression. If Week 8 scan <2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.	Up to 32 months

Secondary Outcomes

Measure	Description	Time Frame
Cohort 1: Overall Survival (OS)		Up to 97 months
Cohort 1: Time to Symptomatic Progression		Up to 97 months
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Urology Centers Of Alabama		Homewood	Alabama	35209	United States
Mayo Clinic Arizona

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42015879	Derived	Ye D, Saad M, Lee JY, Jung W, Pang ST, Li L, Gurney H, Attard G, Chi KN, Mundle S, Zhuo J, Singh A, Lin Y, Sandhu S. Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations: Final Analysis of the Asian Subgroup From the MAGNITUDE Study. Int J Urol. 2026 Apr;33(4):e70455. doi: 10.1111/iju.70455.
39317633

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 30, 2021	Sep 8, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Drug: New Formulation of Niraparib and Abiraterone Acetate (AA)

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
BG001	Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
BG002	Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
BG003	Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
BG004	Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg	Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase.
BG005	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
	BG00069.2± 8.79 BG00168.6± 8.17 BG00271.2± 7.11 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00026 BG00125 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

ARGENTINA

Title	Measurements
	BG0002 BG0015 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; (2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >=2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.

The randomized analysis set for cohort 1 included all randomized participants in Cohort 1. Data for this outcome measure was planned to be collected and analyzed for Cohort 1 only.

Posted

Median

95% Confidence Interval

Months

Up to 32 months

ID	Title	Description
OG000	Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
OG001	Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.

Units	Counts
Participants	OG000212 OG001211

Title

Denominators

Categories

Title	Measurements
	OG00016.46(13.83 to 19.38) OG00113.70(10.91 to 16.39)

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		Log Rank		0.0217		Hazard Ratio (HR)	0.729			2-Sided	95	0.556	0.956					Superiority

Primary

Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan >=6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >=2 new lesions means no progression. If Week 8 scan <2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.

The randomized analysis set for cohort 1 BRCA subgroup included all randomized participants in Cohort 1 BRCA subgroup. Data for this outcome measure was planned to be collected and analyzed for BRCA subgroup of Cohort 1 only.

Posted

Median

95% Confidence Interval

Months

Up to 32 months

ID	Title	Description
OG000	Cohort 1 BRCA Subgroup: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with metastatic castration-resistant prostate cancer (mCRPC) and BRCA alterations, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.

Secondary

Cohort 1: Overall Survival (OS)

Not Posted

Feb 2028

Up to 97 months

Participants

Secondary

Cohort 1: Time to Symptomatic Progression

Not Posted

Feb 2028

Up to 97 months

Participants

Secondary

Cohort 1: Time to Initiation of Cytotoxic Chemotherapy

Not Posted

Feb 2028

Up to 97 months

Participants

Secondary

Observed Plasma Concentrations of Niraparib

Not Posted

Feb 2028

Up to 97 months

Participants

Secondary

Observed Plasma Concentrations of Abiraterone

Not Posted

Feb 2028

Up to 97 months

Participants

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Not Posted

Feb 2028

Up to 96 months

Participants

Secondary

Number of Participants With Treatment-Emergent Adverse Events by Severity

Not Posted

Feb 2028

Up to 96 months

Participants

Secondary

Number of Participants With Abnormalities in Laboratory Values

Not Posted

Feb 2028

Up to 96 months

Participants

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	Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.	55	212	76	212	198	212
EG001	Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.	59	211	52	211	178	211
EG002	Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.	53	123	66	123	117	123
EG003	Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg	Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.	44	123	45	123	108	123
EG004	Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg	Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase.	9	95	21	95	83	95

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00012 affected212 at risk EG0012 affected211 at risk EG00220 affected123 at risk EG0032 affected123 at risk EG0042 affected95 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Lymphoid Tissue Hyperplasia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0003 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0004 affected212 at risk EG0010 affected211 at risk EG0022 affected123 at risk EG003
Acute Coronary Syndrome	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Angina Pectoris	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Angina Unstable	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Arrhythmia Supraventricular	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Cardiac Arrest	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Cardiac Failure	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0011 affected211 at risk EG0023 affected123 at risk EG003
Cardiac Failure Acute	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Cor Pulmonale	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Coronary Artery Disease	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0012 affected211 at risk EG0020 affected123 at risk EG003
Left Ventricular Dysfunction	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Myocardial Infarction	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0003 affected212 at risk EG0013 affected211 at risk EG0020 affected123 at risk EG003
Myocardial Ischaemia	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Palpitations	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Tachycardia	Cardiac disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Adrenal Insufficiency	Endocrine disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Blindness Unilateral	Eye disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Eye Pain	Eye disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Abdominal Mass	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Anal Haemorrhage	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Colitis Ischaemic	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Large Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0023 affected123 at risk EG003
Adverse Drug Reaction	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Asthenia	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Chest Pain	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Fatigue	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0011 affected211 at risk EG0022 affected123 at risk EG003
Gait Disturbance	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
General Physical Health Deterioration	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Non-Cardiac Chest Pain	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Oedema Peripheral	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Pain	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Peripheral Swelling	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0022 affected123 at risk EG003
Pyrexia	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Hepatic Failure	Hepatobiliary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Hepatitis Acute	Hepatobiliary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Abscess Oral	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Bacteraemia	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Cellulitis	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Clostridium Difficile Infection	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0006 affected212 at risk EG0011 affected211 at risk EG0023 affected123 at risk EG003
Covid-19 Pneumonia	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0004 affected212 at risk EG0012 affected211 at risk EG0020 affected123 at risk EG003
Diverticulitis	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Erysipelas	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Escherichia Bacteraemia	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Infection	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Medical Device Site Joint Infection	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Meningitis Aseptic	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0007 affected212 at risk EG0014 affected211 at risk EG0024 affected123 at risk EG003
Post Procedural Sepsis	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Pyelonephritis Acute	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Septic Shock	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Suspected Covid-19	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0012 affected211 at risk EG0020 affected123 at risk EG003
Tooth Infection	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0012 affected211 at risk EG0022 affected123 at risk EG003
Urosepsis	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Cardiac Valve Rupture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Patella Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Post Procedural Pulmonary Embolism	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Radiation Proctitis	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Ulna Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Vaccination Complication	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0022 affected123 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0010 affected211 at risk EG0022 affected123 at risk EG003
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0011 affected211 at risk EG0022 affected123 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Osteonecrosis of Jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Osteoporotic Fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Adenocarcinoma of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Bladder Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Lung Adenocarcinoma Stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0012 affected211 at risk EG0020 affected123 at risk EG003
Squamous Cell Carcinoma of Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Carotid Artery Stenosis	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Cauda Equina Syndrome	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Cerebral Arteriosclerosis	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Depressed Level of Consciousness	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Dysarthria	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Facial Paralysis	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Haemorrhage Intracranial	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Headache	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Ischaemic Cerebral Infarction	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Lumbar Radiculopathy	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Malignant Spinal Cord Compression	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Myelopathy	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Peroneal Nerve Palsy	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Spinal Cord Compression	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Transient Ischaemic Attack	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Vascular Encephalopathy	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Completed Suicide	Psychiatric disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0012 affected211 at risk EG0023 affected123 at risk EG003
Bladder Mass	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Bladder Obstruction	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Bladder Perforation	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Calculus Bladder	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0002 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Chronic Kidney Disease	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0003 affected212 at risk EG0011 affected211 at risk EG0022 affected123 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0012 affected211 at risk EG0021 affected123 at risk EG003
Micturition Disorder	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Renal Failure	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0012 affected211 at risk EG0020 affected123 at risk EG003
Renal Impairment	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Ureteric Obstruction	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0022 affected123 at risk EG003
Urethral Stenosis	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0004 affected212 at risk EG0012 affected211 at risk EG0020 affected123 at risk EG003
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0021 affected123 at risk EG003
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0003 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0004 affected212 at risk EG0011 affected211 at risk EG0023 affected123 at risk EG003
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Actinic Keratosis	Skin and subcutaneous tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Aortic Aneurysm	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Circulatory Collapse	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003
Embolism	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Hypertensive Crisis	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0021 affected123 at risk EG003
Hypovolaemic Shock	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Iliac Artery Rupture	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0000 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Orthostatic Hypotension	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0010 affected211 at risk EG0020 affected123 at risk EG003
Venous Thrombosis Limb	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0001 affected212 at risk EG0011 affected211 at risk EG0020 affected123 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00095 affected212 at risk EG00143 affected211 at risk EG00259 affected123 at risk EG00319 affected123 at risk EG00437 affected95 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00022 affected212 at risk EG0015 affected211 at risk EG0027 affected123 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00019 affected212 at risk EG0014 affected211 at risk EG0028 affected123 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00028 affected212 at risk EG00112 affected211 at risk EG00221 affected123 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00045 affected212 at risk EG00118 affected211 at risk EG00224 affected123 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0008 affected212 at risk EG0011 affected211 at risk EG0025 affected123 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0009 affected212 at risk EG00112 affected211 at risk EG0022 affected123 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00065 affected212 at risk EG00129 affected211 at risk EG00238 affected123 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00010 affected212 at risk EG0018 affected211 at risk EG00210 affected123 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0006 affected212 at risk EG0013 affected211 at risk EG0025 affected123 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00013 affected212 at risk EG0016 affected211 at risk EG0028 affected123 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0003 affected212 at risk EG0013 affected211 at risk EG0027 affected123 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00050 affected212 at risk EG00129 affected211 at risk EG00229 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00028 affected212 at risk EG00114 affected211 at risk EG00217 affected123 at risk EG003
Asthenia	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00033 affected212 at risk EG00119 affected211 at risk EG00222 affected123 at risk EG003
Fatigue	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00056 affected212 at risk EG00135 affected211 at risk EG00229 affected123 at risk EG003
Oedema Peripheral	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00020 affected212 at risk EG00118 affected211 at risk EG00216 affected123 at risk EG003
Pyrexia	General disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00012 affected212 at risk EG00111 affected211 at risk EG0026 affected123 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG0007 affected212 at risk EG0018 affected211 at risk EG0027 affected123 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 24.0	Non-systematic Assessment	EG00019 affected212 at risk EG00111 affected211 at risk EG0029 affected123 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 24.0	Non-systematic Assessment	EG00011 affected212 at risk EG00125 affected211 at risk EG0029 affected123 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA Version 24.0	Non-systematic Assessment	EG00010 affected212 at risk EG00122 affected211 at risk EG0027 affected123 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 24.0	Non-systematic Assessment	EG00011 affected212 at risk EG00120 affected211 at risk EG0026 affected123 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 24.0	Non-systematic Assessment	EG00021 affected212 at risk EG00114 affected211 at risk EG0029 affected123 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA Version 24.0	Non-systematic Assessment	EG00019 affected212 at risk EG0018 affected211 at risk EG0025 affected123 at risk EG003
Weight Decreased	Investigations	MedDRA Version 24.0	Non-systematic Assessment	EG00019 affected212 at risk EG0015 affected211 at risk EG00220 affected123 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00030 affected212 at risk EG00113 affected211 at risk EG00229 affected123 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00021 affected212 at risk EG00118 affected211 at risk EG00218 affected123 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00018 affected212 at risk EG00112 affected211 at risk EG0029 affected123 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00027 affected212 at risk EG00119 affected211 at risk EG00215 affected123 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0004 affected212 at risk EG0015 affected211 at risk EG0022 affected123 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00028 affected212 at risk EG00120 affected211 at risk EG00211 affected123 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00031 affected212 at risk EG00144 affected211 at risk EG00219 affected123 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00021 affected212 at risk EG00124 affected211 at risk EG00210 affected123 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0007 affected212 at risk EG0014 affected211 at risk EG0029 affected123 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG0004 affected212 at risk EG00111 affected211 at risk EG0024 affected123 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00010 affected212 at risk EG00114 affected211 at risk EG0029 affected123 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00024 affected212 at risk EG00112 affected211 at risk EG00213 affected123 at risk EG003
Headache	Nervous system disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00016 affected212 at risk EG00119 affected211 at risk EG0023 affected123 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00022 affected212 at risk EG0018 affected211 at risk EG0028 affected123 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00012 affected212 at risk EG0018 affected211 at risk EG0027 affected123 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00015 affected212 at risk EG00110 affected211 at risk EG0026 affected123 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00033 affected212 at risk EG00112 affected211 at risk EG00215 affected123 at risk EG003
Hot Flush	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00015 affected212 at risk EG00115 affected211 at risk EG0026 affected123 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 24.0	Non-systematic Assessment	EG00066 affected212 at risk EG00144 affected211 at risk EG00241 affected123 at risk EG003

ID	Term
D064129	Prostatic Neoplasms, Castration-Resistant

Ancestor Terms

ID	Term
D011471	Prostatic Neoplasms
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
C545685	niraparib
D000069501	Abiraterone Acetate
D011241	Prednisone

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0042 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0042 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

EG0041 affected95 at risk

EG0040 affected95 at risk

ID	Term
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes