A Study of Enzalutamide Versus Bicalutamide in Castrate M... | NCT01288911

ID	Type	Description	Link
2010-021868-15	EudraCT Number

Status Module

Name	Class
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Enzalutamide	Experimental	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.	Drug: enzalutamide
Bicalutamide	Active Comparator	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.	Drug: bicalutamide

Name	Type	Description	Arm Group Labels	Other Names
enzalutamide	Drug	capsules	Enzalutamide	MDV3100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment	PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.	From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

Secondary Outcomes

Measure	Description	Time Frame
PFS Based on Investigator Assessment	PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Ongoing androgen deprivation therapy with a Luteinizing Hormone Receptor Hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of randomization or bilateral orchiectomy (i.e., surgical or medical castration)
Metastatic disease documented by one of the following:
- At least two bone lesions on bone scan, or
- Soft tissue disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI), or
- Unequivocal pelvic adenopathy short axis > 2.0 cm in diameter by CT/MRI
Progressive disease at study entry defined as one or more of the following three criteria occurring in the setting of castrate levels of testosterone:
- Prostate Specific Antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value should be ≥ 2 µg/L (2 ng/mL);
- Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- Bone disease progression defined by two or more new lesions on bone scan
Asymptomatic or mildly symptomatic from prostate cancer (i.e. the score on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 must be < 4); no use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, including subjects with decreased performance status not attributed to progressive and symptomatic prostate cancer
Estimated life expectancy of ≥ 12 months
Able to swallow the study drug and comply with study requirements
A male subject and his female spouse/partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period, and for 3 months after final study drug administration. Two acceptable forms of birth control include:
1. Condom (barrier method of contraception), AND
2. In addition to a condom, one of the following acceptable forms of contraception is required:
  - Established use of oral, injected or implanted hormonal methods of contraception.
  - Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  - Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  - Tubal ligation for at least 6 months prior to Screening
  - Vasectomy or other surgical castration at least 6 months prior to Screening

Exclusion Criteria:

Prior cytotoxic chemotherapy for prostate cancer
Severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment
Known or suspected brain and/or skull metastasis or active epidural disease
History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
Current or prior treatment with estrogens and/or drugs with anti-androgenic properties such as spironolactone > 50 mg/day, or progestational agents for the treatment of prostate cancer within 6 months prior to randomization
Current or prior use of ketoconazole for the treatment of prostate cancer
Use of antiandrogens within 6 weeks prior to randomization
Documented prior disease progression while receiving antiandrogens. Disease progression defined as PSA progression, radiographic progression and/or clinical deterioration.
Current or prior treatment with 5-α reductase inhibitors or anabolic steroids within 6 months prior to randomization
Prior use of systemic glucocorticoids (the equivalent of 10 mg of prednisone) within 3 months prior to randomization or expectation of their use during the study
Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to randomization
Major surgery within 2 months prior to randomization
History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with anti-epileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months prior to randomization
Clinically significant cardiovascular disease including myocardial infarction within past six months or uncontrolled angina within past three months

Name	Affiliation	Role
Principal Investigator	Carolina Urologic Research Center	Principal Investigator
Associate Medical Science Director	Astellas Pharma Global Development	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site US1934		Homewood	Alabama	35209	United States
Site US1527

PubMed Identifier	Type	Citation	Retractions
30189902	Derived	Schultz NM, Shore ND, Chowdhury S, Klotz LH, Concepcion RS, Penson DF, Karsh LI, Yang H, Brown BA, Barlev A, Flanders SC. Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials. BMC Urol. 2018 Sep 6;18(1):77. doi: 10.1186/s12894-018-0387-7.
27497762

Label	URL
Link to results on the Astellas Clinical Study Results website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
FG001	Bicalutamide

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment

PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.

Full analysis set (all randomized participants)

Posted

Median

95% Confidence Interval

months

From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units	Counts
Participants	OG000184 OG001191

Title

Denominators

Categories

Title	Measurements
	OG00015.7(11.5 to 19.4) OG0015.8(4.8 to 8.1)

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	PFS based on ICR Enzalutamide Vs. Bicalutamide. The (unstratified) log-rank test with an overall significance level of 0.05 (two-sided) was used to compare the PFS of enzalutamide to bicalutamide. The (unstratified) Cox proportional hazards model was used to estimate the hazard ratio of enzalutamide to bicalutamide, calculate the corresponding two-sided 95% confidence intervals and test the hypothesis that the hazard ratio is equal to 1.	Log Rank		<0.0001		Hazard Ratio (HR)	0.44			2-Sided	95	0.34	0.57			Estimated by use of Cox proportional hazards model.		Superiority or Other (legacy)

Secondary

PFS Based on Investigator Assessment

PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first. Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain. The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started.

Full analysis set

Posted

Median

95% Confidence Interval

months

From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Secondary

Prostate-specific Antigen (PSA) Response by Week 13

The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 was set to missing. PSA was analyzed at a central laboratory.

Full analysis set with available PSA data

Posted

Median

Full Range

percent change

Baseline to Week 13

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units

Secondary

Best PSA Response

The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.

Full analysis set with available PSA data

Posted

Median

Full Range

percent change

Baseline to the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units	Counts

Secondary

Time to PSA Progression

Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for participants who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.

Full analysis set

Posted

Median

95% Confidence Interval

months

From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Secondary

Time to PSA ≤ 4 ng/mL

Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization

Full analysis set

Posted

Median

95% Confidence Interval

months

From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units	Counts

Secondary

Time to ≥ 30% PSA Decline From Baseline

The time to ≥ 30% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 30% was recorded. In participants without ≥ 30% PSA decline from Baseline, the time to ≥ 30% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization.

Full analysis set

Posted

Median

95% Confidence Interval

months

From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units

Secondary

Time to ≥ 50% PSA Decline From Baseline

The time to ≥ 50% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 50% was recorded. In participants without ≥ 50% PSA decline from Baseline, the time to ≥ 50% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization.

Full analysis set

Posted

Median

95% Confidence Interval

months

From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units

Secondary

Time to ≥ 90% PSA Decline From Baseline

The time to ≥ 90% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 90% was recorded. In participants without ≥ 90% PSA decline from Baseline, the time to ≥ 90% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization.

Full analysis set

Posted

Median

95% Confidence Interval

months

From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units

Secondary

Radiographic PFS Based on ICR Assessment

Radiographic PFS was calculated as the time interval from the date of randomization to the first date of radiographic disease progression. Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions (a minimum of 2 new bone lesions as compared to previous scan) on bone scan and confirmed by the next bone scan.

Full analysis set

Posted

Median

95% Confidence Interval

months

From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units	Counts

Secondary

Percentage of Participants With an Objective Response

Response assessments were reported by ICR for target lesions in soft tissues and non-target lesions in soft tissues based on CT and/or MRI according to RECIST version 1.1. Objective response was defined as the number of participants achieving either a complete response (CR) or a partial response (PR) based on participant's best overall response assessed at the end of the treatment.

Full analysis set

Posted

Number

percentage of participants

From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Units	Counts

Secondary

Percentage of Participants With Adverse Events

A serious adverse event was defined as any untoward medical occurrence that at any dose: ● Resulted in death ● Was life threatening ● Resulted in persistent or significant disability/incapacity ● Resulted in congenital anomaly or birth defect ● Required inpatient hospitalization or led to prolongation of hospitalization ● Other medically important events. Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment. Treatment emergent adverse events (TEAEs) were defined as adverse events (AEs) that started or worsened after starting administration of study drug through end of the study (i.e., the treatment-emergent period).

Safety Analysis Set (all participants who had initiated at least 1 dose of study drug)

Posted

Number

percentage of participants

From initiation of study drug up to 30 days after last dose of study drug or the 30-day safety follow-up visit, whichever was last (Median duration of treatment was 11.6 months in enzalutamide arm and 5.8 in bicalutamide arm, 12.6 in the total arm).

ID	Title	Description
OG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
OG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

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	Double-blind Period: Enzalutamide	Participants received enzalutamide 160 mg orally once daily in the double-blind period until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.	11	141	49	141	123	141
EG001	Double-blind Period: Bicalutamide	Participants received bicalutamide 50 mg orally once daily in the double-blind period until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.	7	180	43	180	149	180
EG002	Open-label Period: Enzalutamide/Enzalutamide	Participants received enzalutamide in the double-blind period and received enzalutamide in the open-label period as well.	0	42	18	42	42	42
EG003	Open-label Period: Bicalutamide/Enzalutamide	Participants received bicalutamide in the double-blind period and switched over to enzalutamide in the open-label period.	1	9	4	9	9	9

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG0030 events0 affected9 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0011 events1 affected180 at risk EG0021 events1 affected42 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected141 at risk EG0013 events3 affected180 at risk EG0022 events2 affected42 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0012 events2 affected180 at risk EG0022 events2 affected42 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0012 events2 affected180 at risk EG0020 events0 affected42 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
General physical health deterioration	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0022 events2 affected42 at risk EG003
Generalised oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Abscess of salivary gland	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Cystitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected180 at risk EG0021 events1 affected42 at risk EG003
Urosepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0021 events1 affected42 at risk EG003
Arteriogram coronary	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Blood creatinine increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Liver function test abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0022 events2 affected42 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected180 at risk EG0020 events0 affected42 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Joint lock	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected141 at risk EG0012 events2 affected180 at risk EG0020 events0 affected42 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0004 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Basosquamous carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Malignant neoplasm of conjunctiva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0011 events1 affected180 at risk EG0023 events3 affected42 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Penile cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0023 events2 affected42 at risk EG003
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Convulsion	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Epiduritis	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Hypoglycaemic seizure	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Incoherent	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Paraplegia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Presyncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0022 events1 affected42 at risk EG003
Tremor	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Acute prerenal failure	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Bladder obstruction	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0011 events1 affected180 at risk EG0024 events2 affected42 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected180 at risk EG0020 events0 affected42 at risk EG003
Obstructive uropathy	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Postrenal failure	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected180 at risk EG0020 events0 affected42 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Ureteric dilatation	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Urethral obstruction	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected180 at risk EG0022 events2 affected42 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0011 events1 affected180 at risk EG0021 events1 affected42 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0021 events1 affected42 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Transurethral prostatectomy	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00010 events10 affected141 at risk EG0017 events5 affected180 at risk EG0024 events4 affected42 at risk EG0031 events1 affected9 at risk
Angina pectoris	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Palpitations	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Cataract	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Glaucoma	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 events6 affected141 at risk EG0017 events7 affected180 at risk EG0024 events3 affected42 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00021 events19 affected141 at risk EG00125 events24 affected180 at risk EG0027 events5 affected42 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00018 events16 affected141 at risk EG00118 events15 affected180 at risk EG0026 events5 affected42 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected141 at risk EG0014 events4 affected180 at risk EG0021 events1 affected42 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00022 events18 affected141 at risk EG00136 events33 affected180 at risk EG00211 events10 affected42 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected141 at risk EG0011 events1 affected180 at risk EG0021 events1 affected42 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected141 at risk EG00110 events9 affected180 at risk EG0021 events1 affected42 at risk EG003
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment	EG00010 events8 affected141 at risk EG0017 events7 affected180 at risk EG0022 events2 affected42 at risk EG003
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG00040 events35 affected141 at risk EG00145 events38 affected180 at risk EG00224 events18 affected42 at risk EG003
Oedema peripheral	General disorders	MedDRA 16.1	Systematic Assessment	EG00010 events10 affected141 at risk EG00113 events13 affected180 at risk EG0025 events5 affected42 at risk EG003
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0018 events8 affected180 at risk EG0022 events2 affected42 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected180 at risk EG0024 events3 affected42 at risk EG003
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected141 at risk EG0014 events4 affected180 at risk EG0021 events1 affected42 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00013 events11 affected141 at risk EG0018 events7 affected180 at risk EG0029 events7 affected42 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Scrotal infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0008 events7 affected141 at risk EG0013 events3 affected180 at risk EG0024 events4 affected42 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0023 events3 affected42 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG00011 events9 affected141 at risk EG0017 events6 affected180 at risk EG0026 events4 affected42 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0022 events2 affected42 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected141 at risk EG0016 events5 affected180 at risk EG0020 events0 affected42 at risk EG003
Blood urea increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected180 at risk EG0021 events1 affected42 at risk EG003
Haematocrit decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected180 at risk EG0020 events0 affected42 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected141 at risk EG0015 events5 affected180 at risk EG0021 events1 affected42 at risk EG003
Neutrophil count increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Prostatic specific antigen increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected141 at risk EG0012 events2 affected180 at risk EG0021 events1 affected42 at risk EG003
Red blood cell count increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Weight decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG00019 events16 affected141 at risk EG00115 events15 affected180 at risk EG0026 events5 affected42 at risk EG003
White blood cell count increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00019 events16 affected141 at risk EG00113 events13 affected180 at risk EG0023 events2 affected42 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected141 at risk EG0011 events1 affected180 at risk EG0023 events3 affected42 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected180 at risk EG0024 events3 affected42 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected180 at risk EG0022 events2 affected42 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0013 events3 affected180 at risk EG0021 events1 affected42 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00022 events16 affected141 at risk EG00139 events27 affected180 at risk EG00211 events9 affected42 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00039 events29 affected141 at risk EG00140 events34 affected180 at risk EG00215 events11 affected42 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00013 events10 affected141 at risk EG00115 events12 affected180 at risk EG0021 events1 affected42 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected141 at risk EG0012 events2 affected180 at risk EG0023 events3 affected42 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0008 events6 affected141 at risk EG0014 events4 affected180 at risk EG0023 events3 affected42 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0009 events8 affected141 at risk EG00123 events17 affected180 at risk EG0025 events5 affected42 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00010 events9 affected141 at risk EG0015 events5 affected180 at risk EG0022 events1 affected42 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected141 at risk EG0012 events2 affected180 at risk EG0024 events4 affected42 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0026 events4 affected42 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00022 events16 affected141 at risk EG00112 events9 affected180 at risk EG0028 events5 affected42 at risk EG003
Amnesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected141 at risk EG0010 events0 affected180 at risk EG0022 events2 affected42 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00015 events12 affected141 at risk EG00116 events15 affected180 at risk EG0026 events6 affected42 at risk EG003
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00014 events11 affected141 at risk EG0016 events6 affected180 at risk EG00210 events8 affected42 at risk EG003
Lethargy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected141 at risk EG0014 events4 affected180 at risk EG0023 events3 affected42 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Poor quality sleep	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected180 at risk EG0020 events0 affected42 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected180 at risk EG0020 events0 affected42 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0009 events9 affected141 at risk EG0018 events8 affected180 at risk EG0021 events1 affected42 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected141 at risk EG0014 events4 affected180 at risk EG0021 events1 affected42 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0005 events3 affected141 at risk EG0017 events6 affected180 at risk EG0025 events5 affected42 at risk EG003
Hypertonic bladder	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0011 events1 affected180 at risk EG0020 events0 affected42 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0007 events7 affected141 at risk EG0016 events6 affected180 at risk EG0021 events1 affected42 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0023 events3 affected42 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected141 at risk EG0017 events5 affected180 at risk EG0021 events1 affected42 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected141 at risk EG0012 events2 affected180 at risk EG0026 events6 affected42 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected141 at risk EG0010 events0 affected180 at risk EG0021 events1 affected42 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected180 at risk EG0021 events1 affected42 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected141 at risk EG0018 events8 affected180 at risk EG0022 events2 affected42 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 events7 affected141 at risk EG00110 events9 affected180 at risk EG0028 events4 affected42 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected141 at risk EG0011 events1 affected180 at risk EG0021 events1 affected42 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Jaw operation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected180 at risk EG0020 events0 affected42 at risk EG003
Hot flush	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00016 events15 affected141 at risk EG00117 events17 affected180 at risk EG00212 events12 affected42 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00029 events18 affected141 at risk EG00116 events14 affected180 at risk EG00216 events13 affected42 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected180 at risk EG0021 events1 affected42 at risk EG003

ID	Term
D011471	Prostatic Neoplasms
D009362	Neoplasm Metastasis
D009369	Neoplasms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Enzalutamide	Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
BG001	Bicalutamide	Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
BG002	Total	Total of all reporting groups