A Study of Enzalutamide Plus Androgen Deprivation Therapy... | NCT02677896

ID	Type	Description	Link
2015-003869-28	EudraCT Number

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

Label	Type	Description	Intervention Names
Enzalutamide + Androgen Deprivation Therapy (ADT)	Experimental	Participants received 160 mg enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.	Drug: Enzalutamide
Placebo + Androgen Deprivation Therapy (ADT)	Placebo Comparator	Participants received matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.	Drug: Placebo
Placebo followed by Enzalutamide	Experimental	Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Name	Type	Description	Arm Group Labels	Other Names
Enzalutamide	Drug	Oral	Enzalutamide + Androgen Deprivation Therapy (ADT) Placebo followed by Enzalutamide

Measure	Description	Time Frame
Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria	rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to PCWG2 criteria, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.	From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)
rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria	rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.	From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. In participants still alive at the date of the analysis cutoff point, OS was censored on the last date the participant was known to be alive. OS was analyzed using Kaplan-Meier estimates.	From randomization to death due to any cause (maximum duration was 58.6 months)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is considered an adult according to local regulation at the time of signing informed consent.
Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
Subject has metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan (for soft tissue). Subjects whose disease spread is limited to regional pelvic lymph nodes are not eligible.
Once randomized at day 1, subject must maintain ADT with an LHRH agonist or antagonist during study treatment or have a history of bilateral orchiectomy (i.e., medical or surgical castration).
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Inclusion Criteria for Open-Label Extension:

Subject received randomized double-blind treatment in ARCHES
Subject has not met any of the discontinuation criteria in the main ARCHES protocol
Subject is willing to maintain ADT with LHRH agonist or antagonist or has had a bilateral orchiectomy.
Subject is able to swallow enzalutamide capsules whole and to comply with study requirements throughout the study
Subject and subject's female partner agree to follow contraception and sperm donation requirements in main protocol

Exclusion Criteria:

Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
- Up to 3 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
- Subject may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to day 1;
- Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of day 1 and no evidence of disease progression during or after the completion of docetaxel therapy;
- Up to 6 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
- Prior ADT given for < 39 months in duration and > 9 months before randomization as neoadjuvant/adjuvant therapy.
Subject had a major surgery within 4 weeks prior to day 1.
Subject received treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks prior to day 1.
Subject received treatment with estrogens, cyprotoerone acetate or androgens within 4 weeks prior to day 1.
Subject received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1, intended for the treatment of prostate cancer.
Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1.
Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate or enzalutamide for the treatment of prostate cancer or participation in a clinical study of an investigational agent that inhibits the AR or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
Subject has known or suspected brain metastasis or active leptomeningeal disease.
Subject has absolute neutrophil count < 1500/μL, platelet count < 100000/μL or hemoglobin < 10 g/dL (6.2 mmol/L).
Subject has total bilirubin (TBL) ≥ 1.5 x the upper limit of normal (ULN) (except subjects with documented Gilbert's disease), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x the ULN .
Subject has creatinine > 2 mg/dL (177 μmol/L).
Subject has albumin < 3.0 g/dL (30 g/L).
Subject has a history of seizure or any condition that may predispose to seizure.
Subject has history of loss of consciousness or transient ischemic attack within 12 months prior to day 1.
Subject has clinically significant cardiovascular disease.
Subject received bisphosphonates or denosumab within 2 weeks prior to day 1 unless administered at stable dose or to treat diagnosed osteoporosis

Exclusion Criteria for Open-Label Extension:

Subject has taken commercially available enzalutamide (Xtandi).
Subject's disease has progressed radiographically during the double-blind period of the study and treatment with study drug was stopped prior to study-wide unblinding. (Note: Subjects who progressed radiographically while in the double-blind portion of the study and continued treatment per protocol are allowed to participate in the open label extension.)
After study-wide unblinding, subject has started any new investigational agent or anti-neoplastic therapy intended to treat prostate cancer
Subject has any clinically significant disorder or condition including excessive alcohol or drug abuse, or secondary malignancy, which may interfere with study participation
Subject has current or previously treated brain metastasis or active leptomeningeal disease
Subject has a history of seizure or any condition that may increase the risk of seizure

Name	Affiliation	Role
Medical Director	Astellas Pharma Global Development, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site US10016		Homewood	Alabama	35209	United States
Site US10007

PubMed Identifier	Type	Citation	Retractions
31329516	Result	Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore ND, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019 Nov 10;37(32):2974-2986. doi: 10.1200/JCO.19.00799. Epub 2019 Jul 22.
41894648

Label	URL
Link to results and other applicable study documents on the Astellas Clinical Trials website.	View source

ID	Title	Description
FG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 18, 2022	May 23, 2025

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

Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria

rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to PCWG2 criteria, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.

ITT population is defined as all participants who were randomized in this study.

Posted

Median

95% Confidence Interval

months

From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
OG001	Placebo + Androgen Deprivation Therapy (ADT)	Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Units	Counts
Participants	OG000574 OG001576

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Not reached. Data was not reached due to low number of events. OG00119.4(16.59 to NA)Not reached. Data was not reached due to low number of events.

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	rPFS Treatment Comparison	Log Rank		<0.0001	Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.	Cox hazard ratio	0.39			2-Sided	95	0.30	0.50			Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.		Superiority

Primary

rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria

rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.

ITT

Posted

Median

95% Confidence Interval

months

From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Secondary

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. In participants still alive at the date of the analysis cutoff point, OS was censored on the last date the participant was known to be alive. OS was analyzed using Kaplan-Meier estimates.

ITT population

Posted

Median

95% Confidence Interval

months

From randomization to death due to any cause (maximum duration was 58.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
OG001	Placebo + Androgen Deprivation Therapy (ADT)	Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Secondary

Time to Prostate Specific Antigen (PSA) Progression

Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. A PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which was confirmed by a second consecutive value at least 3 weeks later. In participants with no PSA progression, time to PSA progression was censored on the date of the last PSA sample taken (or last value prior to 2 or more consecutive missed PSA assessments).

ITT

Posted

Median

95% Confidence Interval

months

From the date of randomization to the first observation of PSA progression (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
OG001

Secondary

Time to Start of New Antineoplastic Therapy

In participants with a new antineoplastic therapy initiated for prostate cancer after randomization, time to start of a new antineoplastic therapy was defined as the time interval from randomization to the date of the first dose administration of the first antineoplastic therapy. In participants with no new antineoplastic therapy initiated for prostate cancer after randomization, time to start of new antineoplastic therapy was censored on the last visit date or the date of randomization, whichever occurred last. Time to start of new antineoplastic therapy was analyzed using Kaplan-Meier estimates.

ITT Population

Posted

Median

95% Confidence Interval

months

From randomization to the date of the first dose administration of the first antineoplastic therapy (maximum duration was 58.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Secondary

PSA Undetectable Rate

The PSA undetectable rate was defined as the percentage of participants with undetectable (< 0.2 ng/mL) PSA values at any time during study treatment, of those participants with detectable (≥ 0.2 ng/mL) PSA values at baseline.

ITT with detectable PSA at baseline

Posted

Number

95% Confidence Interval

percentage of participants

From baseline to detectable PSA values (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
OG001	Placebo + Androgen Deprivation Therapy (ADT)	Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Secondary

Objective Response Rate (ORR)

The ORR was calculated as the percentage of participants who achieved a completed response (CR) or a partial response (PR) (unconfirmed responses) in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by ICR.

ITT participants with measurable disease at baseline

Posted

Number

95% Confidence Interval

percentage of participants

From date of randomization up to 26.6 months

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
OG001	Placebo + Androgen Deprivation Therapy (ADT)	Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Secondary

Time to Deterioration in Urinary Symptoms

In participants with deterioration, the time to deterioration was calculated as the time interval between randomization and the first deterioration in urinary symptoms at any postbaseline visit. A deterioration in urinary symptoms was defined as an increase in the Quality of Life Prostate-specific Questionnaire (QLQ-PR25) modified urinary symptoms. Subscale score by ≥ 50% of the standard deviation observed in the QLQ-PR25 modified urinary symptoms subscale score at baseline. Modified urinary symptoms subscale score consisted of 3-items (Q31 - Q33) from the QLQ-PR25, each scored from 1 (not at all) to 4 (very much). The total modified urinary symptoms subscale score ranges from 0-100, with higher scores represents a higher level of symptomatology/problems. In participants without deterioration in urinary symptoms, the time to deterioration in urinary symptoms was censored on the date the last urinary symptoms QLQ-PR25 score was calculable.

ITT

Posted

Median

95% Confidence Interval

months

From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Secondary

Time to First Symptomatic Skeletal Event (SSE)

Time to first SSE was calculated as the time from randomization to the occurrence of the first SSE. An SSE was defined as radiation to bone, surgery to bone, clinically apparent pathological bone fracture, or spinal cord compression. In participants with no SSE, time to SSE was censored on the last visit date or the date of randomization, whichever occurred last.

ITT

Posted

Median

95% Confidence Interval

months

From randomization to the occurrence of the first SSE (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
OG001	Placebo + Androgen Deprivation Therapy (ADT)

Secondary

Time to Castration Resistance

Time to castration resistance was calculated as the time from randomization to the first castration-resistant event. A castration resistance event was defined as any of the following in the presence of castrate levels of testosterone (< 50 ng/dL): radiographic disease progression, PSA progression or SSE, whichever occurred first. In participants with no documented castration resistance event, the time to castration resistance was censored on the latest date from: the date of last radiologic assessment, the last PSA sample taken prior to the start of any new prostate cancer therapy and prior to 2 or more consecutive missed PSA assessments (if applicable), and the last visit date performed.

ITT

Posted

Median

95% Confidence Interval

months

From randomization to the first castration-resistant event (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Secondary

Time to Deterioration of Quality of Life (QoL) in Functional Assessment of Cancer Therapy-Prostate (FACT-P)

Time to deterioration of QoL was calculated as the time interval from the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score was recorded. The FACT-P consists of 27 core items that assess participant function in 4 domains and 12 prostate cancer-related items grouped into 5 subscales as follows: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and prostate cancer subscale. Each item is rated on a 0 to 4 Likert-type scale. The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0 to 156), where high score represent better quality of life. In participants without FACT-P progression, the time to deterioration of QoL was censored on the date of the last FACT-P total score was calculable.

ITT

Posted

Median

95% Confidence Interval

months

From the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Secondary

Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)

Time to pain progression was defined as time from randomization to the first pain progression event. Pain progression was defined as an increase of ≥ 30% from baseline in the average BPI-SF pain severity score. BPI-SF contains 9 questions with rating scales from 0 (no pain/no interference) to 10 (worst pain/interferes completely). Total score was calculated as the average of each question. Higher scores represent a higher level of pain or interference. In participants with no pain progression event, time to pain progression was censored on the last visit date where BPI-SF was collected.

ITT

Posted

Median

95% Confidence Interval

months

From randomization to the first pain progression event (maximum duration was 26.6 months)

ID	Title	Description
OG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v26	Systematic Assessment	EG00011 events7 affected572 at risk EG0014 events2 affected574 at risk EG0021 events1 affected182 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA v26	Systematic Assessment	EG0006 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v26	Systematic Assessment	EG0003 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0004 events4 affected572 at risk EG0011 events1 affected574 at risk EG0022 events2 affected182 at risk
Angina pectoris	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0008 events4 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Angina unstable	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v26	Systematic Assessment	EG00013 events10 affected572 at risk EG00110 events7 affected574 at risk EG0022 events2 affected182 at risk
Atrial flutter	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Atrioventricular block	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Bradycardia	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Cardiac arrest	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0022 events2 affected182 at risk
Cardiac failure	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0008 events6 affected572 at risk EG0011 events1 affected574 at risk EG0022 events2 affected182 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0003 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Coronary artery disease	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0004 events4 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0022 events2 affected182 at risk
Myocardial infarction	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0005 events5 affected572 at risk EG0012 events2 affected574 at risk EG0022 events2 affected182 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Trifascicular block	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Deafness	Ear and labyrinth disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Goitre	Endocrine disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cataract	Eye disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0027 events5 affected182 at risk
Eye haemorrhage	Eye disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Retinal detachment	Eye disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Ulcerative keratitis	Eye disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Constipation	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0003 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Duodenitis	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0012 events2 affected574 at risk EG0021 events1 affected182 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Epiploic appendagitis	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Gastritis	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0003 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Nausea	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Proctalgia	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Retroperitoneal fibrosis	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Subileus	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0004 events2 affected572 at risk EG0012 events1 affected574 at risk EG0021 events1 affected182 at risk
Asthenia	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Chills	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Death	General disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Drowning	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Fatigue	General disorders	MedDRA v26	Systematic Assessment	EG0005 events4 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
General physical health deterioration	General disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0013 events2 affected574 at risk EG0023 events2 affected182 at risk
Implant site dehiscence	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Malaise	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pyrexia	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0022 events1 affected182 at risk
Sudden cardiac death	General disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Sudden death	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0012 events2 affected574 at risk EG0021 events1 affected182 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0012 events1 affected574 at risk EG0020 events0 affected182 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0025 events3 affected182 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Anorectal infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Appendicitis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Bronchitis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
COVID-19	Infections and infestations	MedDRA v26	Systematic Assessment	EG00012 events7 affected572 at risk EG0010 events0 affected574 at risk EG0023 events2 affected182 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA v26	Systematic Assessment	EG0004 events3 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Cellulitis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0004 events3 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Cholecystitis infective	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Cystitis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Device related infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Diverticulitis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0003 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Endocarditis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Erysipelas	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0012 events2 affected574 at risk EG0021 events1 affected182 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0022 events2 affected182 at risk
Gangrene	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Gastroenteritis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Genital abscess	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Groin abscess	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Infected lymphocele	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Influenza	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Osteomyelitis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Otitis media chronic	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pneumonia	Infections and infestations	MedDRA v26	Systematic Assessment	EG00013 events9 affected572 at risk EG0016 events5 affected574 at risk EG0021 events1 affected182 at risk
Pyelonephritis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Sepsis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0005 events4 affected572 at risk EG0013 events3 affected574 at risk EG0023 events2 affected182 at risk
Septic shock	Infections and infestations	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Spinal cord infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Subcutaneous abscess	Infections and infestations	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Systemic candida	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Urinary tract infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Urosepsis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG00012 events12 affected572 at risk EG0014 events4 affected574 at risk EG0022 events2 affected182 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0004 events4 affected572 at risk EG0013 events3 affected574 at risk EG0023 events2 affected182 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0006 events6 affected572 at risk EG0011 events1 affected574 at risk EG0022 events2 affected182 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0004 events3 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0004 events4 affected572 at risk EG0010 events0 affected574 at risk EG0023 events3 affected182 at risk
Stenosis of vesicourethral anastomosis	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0003 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Urinary tract stoma complication	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Wound	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Wrong dose	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Alanine aminotransferase increased	Investigations	MedDRA v26	Systematic Assessment	EG0003 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Antineutrophil cytoplasmic antibody increased	Investigations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v26	Systematic Assessment	EG0003 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Blood bilirubin increased	Investigations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Blood creatinine increased	Investigations	MedDRA v26	Systematic Assessment	EG0003 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Blood testosterone increased	Investigations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0012 events1 affected574 at risk EG0020 events0 affected182 at risk
Intraocular pressure increased	Investigations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Liver function test abnormal	Investigations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Transaminases increased	Investigations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0012 events2 affected574 at risk EG0022 events2 affected182 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0007 events6 affected572 at risk EG0015 events5 affected574 at risk EG0024 events2 affected182 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0015 events3 affected574 at risk EG0022 events1 affected182 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0024 events1 affected182 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0022 events1 affected182 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Lung adenocarcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Lung adenocarcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG00010 events5 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0003 events2 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG00014 events13 affected572 at risk EG0014 events3 affected574 at risk EG0026 events4 affected182 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Paraproteinaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Penile cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Squamous cell carcinoma of head and neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0014 events1 affected574 at risk EG0020 events0 affected182 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Altered state of consciousness	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Aphasia	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cerebellar infarction	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cerebral infarction	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0006 events5 affected572 at risk EG0011 events1 affected574 at risk EG0023 events3 affected182 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Cognitive disorder	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Dementia	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Dizziness	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Facial paralysis	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Headache	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Hemianopia	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0021 events1 affected182 at risk
Lethargy	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Loss of consciousness	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Memory impairment	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Monoparesis	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Paraparesis	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Seizure	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0012 events2 affected574 at risk EG0020 events0 affected182 at risk
Spinal cord compression	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0017 events7 affected574 at risk EG0021 events1 affected182 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Syncope	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0005 events5 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Transient global amnesia	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0004 events4 affected572 at risk EG0013 events2 affected574 at risk EG0021 events1 affected182 at risk
Device occlusion	Product Issues	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Completed suicide	Psychiatric disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Confusional state	Psychiatric disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Delirium	Psychiatric disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0012 events2 affected574 at risk EG0021 events1 affected182 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG00011 events7 affected572 at risk EG0013 events3 affected574 at risk EG0023 events1 affected182 at risk
Bladder mass	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Bladder perforation	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Calculus bladder	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Dysuria	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Haematuria	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG00013 events9 affected572 at risk EG0012 events2 affected574 at risk EG0021 events1 affected182 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0004 events4 affected572 at risk EG0014 events3 affected574 at risk EG0021 events1 affected182 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Renal colic	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Renal failure	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Renal impairment	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0012 events1 affected574 at risk EG0020 events0 affected182 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Urinary retention	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0009 events9 affected572 at risk EG0014 events4 affected574 at risk EG0022 events2 affected182 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Diaphragmatic paralysis	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0004 events2 affected572 at risk EG0012 events2 affected574 at risk EG0022 events2 affected182 at risk
Eosinophilic pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0007 events6 affected572 at risk EG0013 events3 affected574 at risk EG0026 events5 affected182 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0006 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Bone lesion excision	Surgical and medical procedures	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Aortic aneurysm	Vascular disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Aortic dissection	Vascular disorders	MedDRA v26	Systematic Assessment	EG0003 events3 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Aortic dissection rupture	Vascular disorders	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Circulatory collapse	Vascular disorders	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0027 events3 affected182 at risk
Embolism	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Essential hypertension	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Granulomatosis with polyangiitis	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Haematoma	Vascular disorders	MedDRA v26	Systematic Assessment	EG0003 events2 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Hypertensive crisis	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Hypotension	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Hypovolaemic shock	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Lymphoedema	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Peripheral embolism	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Peripheral ischaemia	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Phlebitis	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Thrombosis	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Vena cava thrombosis	Vascular disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Venous thrombosis	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cardiac failure acute	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0022 events2 affected182 at risk
Cardiac pseudoaneurysm	Cardiac disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Vertigo	Ear and labyrinth disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Epiretinal membrane	Eye disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Visual impairment	Eye disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Ascites	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Vomiting	Gastrointestinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Chest pain	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Non-cardiac chest pain	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Oedema peripheral	General disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Cholangitis	Hepatobiliary disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Diabetic gangrene	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Mycobacterium avium complex infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Oral infection	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Periodontitis	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Pneumonia aspiration	Infections and infestations	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0011 events1 affected574 at risk EG0022 events1 affected182 at risk
Flail chest	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0022 events1 affected182 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA v26	Systematic Assessment	EG0002 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v26	Systematic Assessment	EG0002 events2 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Soft tissue sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Cerebral artery stenosis	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Myelopathy	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Nerve compression	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Polyneuropathy	Nervous system disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA v26	Systematic Assessment	EG0000 events0 affected572 at risk EG0010 events0 affected574 at risk EG0021 events1 affected182 at risk
Loss of personal independence in daily activities	Social circumstances	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Euthanasia	Surgical and medical procedures	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0011 events1 affected574 at risk EG0020 events0 affected182 at risk
Embolism arterial	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Embolism venous	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Haemodynamic instability	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA v26	Systematic Assessment	EG0001 events1 affected572 at risk EG0010 events0 affected574 at risk EG0020 events0 affected182 at risk

ID	Title	Description
BG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
BG001	Placebo + Androgen Deprivation Therapy (ADT)	Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Enzalutamide + Androgen Deprivation Therapy (ADT)	Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.	190	574	244	572	463	572
EG001	Placebo + ADT	Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. This arm represents only double blind period.	197	576	128	574	401	574
EG002	Placebo Cross-over Enzalutamide	Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock. This arm represents only the open-label extension period.	27	182	81	182	133	182