Study to Compare the Efficacy and Safety of Combination T... | NCT02058368

Label	Type	Description	Intervention Names
Arm 1	Experimental	Run-in phase: All subjects qualifying for the study will entered into a placebo run-in phase will receive one soft gelatin placebo capsule (swallowed whole and not chewed) and one oral disintegrating placebo tablet once daily (OD) (dissolved on the tongue then swallowed not chewed), following the first meal each day for four weeks. Randomized treatment phase: Subjects will be instructed to take 1 dutasteride 0.5 milligram (mg) capsule (swallowed whole and not chewed) and one tamsulosin 0.2mg tablet OD (dissolved on the tongue then swallowed not chewed) following the first meal each day for 104 weeks.	Drug: Dutasteride 0.5mg capsules Drug: Dutasteride placebo capsules Drug: Tamsulosin 0.2mg tablets Drug: Disintegrating placebo tamsulosin tablet
Arm 2	Experimental	Run-in phase: All subjects qualifying for the study will entered into a placebo run-in phase will receive one soft gelatine placebo capsule (swallowed whole and not chewed) and one oral disintegrating placebo tablet OD (dissolved on the tongue then swallowed not chewed), following the first meal each day for four weeks. Randomized treatment phase: Subjects will be instructed to take 1 placebo dutasteride 0.5mg capsule (swallowed whole and not chewed) and one tamsulosin 0.2mg tablet OD (dissolved on the tongue then swallowed not chewed) following the first meal each day for 104 weeks.	Drug: Dutasteride placebo capsules Drug: Tamsulosin 0.2mg tablets Drug: Disintegrating placebo tamsulosin tablet

Name	Type	Description	Arm Group Labels	Other Names
Dutasteride 0.5mg capsules	Drug	Dutasteride 0.5mg capsules will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules.	Arm 1

Measure	Description	Time Frame
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value.	Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months

Measure	Description	Time Frame
Percent Change in Prostate Volume From Baseline	Prostate Volume measurements were conducted annually using Transrectal ultrasound (TRUS). The following calculation was utilized to assess the prostate volume (cc): pi/6 (Anteroposterior Width multiplied by Cephalocaudal Width multiplied by Transverse Width). Post-Baseline prostate volume was calculated at 12 and 24 months. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value and reported as a percentage.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males, aged >=50 years
Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
International Prostate Symptom Score (IPSS) >=12 points at Screening
Prostate volume >=30cc (by TRUS)
Total serum Prostate Specific Antigen (PSA) >=1.5ng/mL and <= 10 ng/mL at Screening
Maximum urinary flow rate (Qmax) >5mL/sec and 15mL/sec and minimum voided volume of >=125 milliliter (mL) at Screening
Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Fluent and literate in local language with the ability to comprehend and record information on the IPSS, BPH-related Health Status (BHS), BPH Impact Index (BII), and Problem Assessment Scale Sexual Function Inventory (PAS- SFI) questionnaires
Men with a female partner of childbearing potential must agree to use a condom up to 6 months after the last dose (applies only to countries where the local product monograph for dutasteride mandates condom use for men with a female partner of childbearing potential)

Exclusion Criteria:

History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious Digital Rectal Examination [DRE]). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study. Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, including consideration of prostate biopsy.
Previous prostatic surgery (including TURP, laser, transrectal high intensity focused ultrasounds(HIFU), thermotherapy, transurethral needle ablation (TUNA), balloon dilatation, and stent replacement) or other invasive procedures to treat BPH.
History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Catheterisation (<10F) is acceptable with no time restriction.
History of AUR within 3 months prior to Screening Visit.
Post-void residual volume >250mL (suprapubic ultrasound) at Screening.
Any conditions other than BPH, which may in the judgment of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
Unstable liver disease (chronic stable hepatitis B and C are acceptable if subject meets entry criteria).
History of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal at Screening.
Any unstable, serious co-existing medical condition(s) including, but not limited to:
1. Myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
2. Postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
3. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to study procedures in the opinion of the investigator or GSK medical monitor. Investigator may consult with GSK Medical Monitor if condition could interfere with subject's safety
4. History of breast cancer or clinical breast examination finding suggestive of malignancy.
5. History of malignancy within the past five years, except for basal cell carcinoma of the skin. Subjects with a priori malignancy who have had no evidence of disease for at least the past 5 years are eligible.
Current or Previous Use of the following medications:
1. Use of any 5-alpha-reductase inhibitor (e.g. finasteride), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents), or other drugs noted for gynaecomastia effects, or that could affect prostate volume, within the 6 months preceding the historical TRUS or Screening Visit and throughout the study (other than as study medication). Previous use of dutasteride should not be within 6 months of the baseline or historical TRUS.
2. Anabolic steroids (subject must discontinue for 6 months prior to study entry to be eligible) and agree not to take them for the duration of the study.
3. Phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study.
4. Use of any alpha-adrenoreceptor blockers within 2 weeks of Screening Visit (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin, doxazosin, silodosin) and/or predicted to need any alpha blockers other than the study prescribed tamsulosin.
5. Use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephedrine, ephedrine) or anticholinergics (e.g. oxybutynin,tolterodine, darifenacin, solifenacin,propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments.
Hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
Participation in any investigational or marketed drug trial within 30 days (or 5 half-lives of drug, whichever is the longer) preceding the Screening Visit and/or plans to participate in such a trial during the course of this study.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Xiame	Fujian		China
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
30198102	Background	Haque N, Masumori N, Sakamoto S, Ye Z, Yoon SJ, Kuo HC, Brotherton B, Wilson T, Muganurmath C, McLaughlin M, Manyak M. Superiority of dutasteride 0.5 mg and tamsulosin 0.2 mg for the treatment of moderate-to-severe benign prostatic hyperplasia in Asian men. Int J Urol. 2018 Nov;25(11):944-951. doi: 10.1111/iju.13785. Epub 2018 Sep 9.

Label	URL
IPD for this study will be made available via the Clinical Study Data Request site.	View source

ID	Title	Description
FG000	Placebo +Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
FG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 8, 2014	Feb 21, 2018

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

Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months

IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value.

ITT Population.

Posted

Mean

Standard Error

Score on scale

Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants	OG000302 OG001305

Title

Denominators

Categories

Month 3, n=299, 296

- ParticipantsOG000299
- ParticipantsOG001296

Title	Measurements
	OG000-4.07± 0.34

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		General linear model		0.069	Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2mg are based on t-tests from the general linear model. Reported means are model based adjusted means.	Mean Difference (Final Values)	0.79			2-Sided	95	-0.06	1.65			Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 3.		Superiority

Secondary

Percent Change in Prostate Volume From Baseline

Prostate Volume measurements were conducted annually using Transrectal ultrasound (TRUS). The following calculation was utilized to assess the prostate volume (cc): pi/6 (Anteroposterior Width multiplied by Cephalocaudal Width multiplied by Transverse Width). Post-Baseline prostate volume was calculated at 12 and 24 months. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value and reported as a percentage.

ITT Population.

Posted

Mean

Standard Error

Cubic centimeters (cc)

Baseline,12 and 24 months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants

Secondary

Number of Participants With IPSS Improvement From Baseline

Improvement in IPSS was categorized as improvement, no change and worsening. Improvement defined as greater than or equal to 2 points, greater than or equal to 3 points and greater than or equal to 25 percent in participants at months 3,6,9,12,15,18,21 and 24 . Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value.

ITT Population.

Posted

Number

Participants

Baseline and 3, 6, 9,12,15,18,21 and 24 months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach

Qmax is defined as maximum urine flow. Qmax was measured with Uroflow meter (Urodyn 1000) at Screening, Baseline, and at Months 6,12,18 and 24. Change from Baseline Qmax at each scheduled post-Baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline Qmax. Baseline value was defined as the latest non-missing assessment either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population

Posted

Mean

Standard Error

milliliter per second (mL/sec)

Baseline, 6, 12, 18 and 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Secondary

Number of Participants With Qmax Improvement From Baseline by LOCF Approach.

Qmax change from Baseline was presented using six improvement levels: >0 milliliter per second (mL/sec) and >=1 mL/sec through >=5mL/sec. Qmax percentage change from Baseline was presented using six improvement levels: >0%, >=10%, >=20%, >=30%, >=40%, and >=50%. Here, Qmax improvement of >= 3 mL/sec and Qmax percentage of >= 30 % for 24 Months has been summarized. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date.

ITT Population.

Posted

Count of Participants

Participants

Baseline 6, 12, 18 and 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts

Secondary

Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery

AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization. AUR or BPH-related surgery event details per participant was summarized as first occurring of either AUR or BPH-related surgery.

ITT Population.

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With AUR

AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization.

ITT Population.

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With BPH-related Surgery

BPH-related interventions were recorded. BPH-related interventions included adenomectomy, balloon dilatation, electroresection, thermotherapy (microwave or radiofrequency), laser resection, prostatectomy, prostatotomy, transurethral resection of the prostate, transurethral drainage of prostatic abscess, drainage of prostatic cysts, radioactive seeding of the prostate, prostatic urethral stenting, incision of periurethral stricture, ethanol injections into the prostate, transrectal high intensity focussed ultrasound, transurethral needle ablation and transurethral microwave thermotherapy.

ITT Population.

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants

Secondary

Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach

BHS was collected as Question 8 the IPSS questionnaire regarding quality of life due to urinary symptom with scores values ranging from 0 (delightful) to 6 (terrible). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from baseline BHS at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BHS.

ITT Population.

Posted

Mean

Standard Deviation

Scores on scale

Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants

Secondary

Change From Baseline in BPH Impact Index (BII) by LOCF Approach

The BII consists of four questions and BII total score is the sum of four questions. Total score range is 0 (no problem) to 13 (worst value). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline BII at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BII. Change from Baseline was summarized using LOCF approaches.

ITT Population.

Posted

Mean

Standard Error

Scores on scale

Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)

PAS SFI consists of three questions each with a range of 0 (Big Problem) to 4 (No Problem). PAS SFI was administered at screening, Baseline and at each month 12 and 24. The total PSI is the sum of the three questions; the total score range is 0 to 12. Change from Baseline PAS SFI at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline PAS SFI. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population.

Posted

Mean

Standard Deviation

Scores on scale

Baseline, 12 and 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Secondary

Number of Hospitalization Days

Duration of hospitalization days due to AUR or BPH-related surgery was recorded.

ITT Population. Only those participants with data available at specific time point were analyzed

Posted

Median

Full Range

Days

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants in a Hospital Ward

Details of number of participants in different types of wards was recorded. Types of wards included general ward, recovery, intensive care unit, multiple ward types and others

ITT Population. Only those participants with data available at specific time point were analyzed

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Hospital Admissions

Details of participants who were admitted to hospitals related to AUR or BPH-Related surgery has been recorded.

ITT Population. Only those participants with data available at specific time point were analyzed.

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)

An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation that is medically important, All events of possible drug-induced liver injury with hyperbilirubinaemia, male breast cancer and spontaneous abortion of a female partner of a male subject

ITT Population.

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Serum Prostate Specific Antigen (PSA)

Total serum PSA concentrations were assessed at pre-screening, month 6, 12 and 24. Change from baseline total PSA was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment at each scheduled post-baseline assessment using a general linear model with effects for treatment and baseline total PSA. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population.

Posted

Mean

Standard Deviation

nanogram/milliliter (ng/mL)

Baseline 6, 12 and 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts

Secondary

Number of Participants With Vital Signs Exceeding Threshold Values

Vital signs included assessment of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. Threshold ranges for SBP ranged from < 80 mmHg (millimeter of mercury) (lower) to > 165 mmHg (upper); for DBP ranged from < 40 mmHg (lower) to > 105 mmHg (upper) and heart rate < 40 beats per minute (bpm) (lower) to > 100 bpm (upper).

ITT Population.

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Post Void Residual Volume

Post void residual volume was measured suprapubically by ultrasound (immediately following the urinary flow measurement). Post void residual volume change from Baseline distribution at each scheduled post-Baseline assessment was compared with combination treatment (Dut plus Tam) versus tamsulosin treatment using a nonparametric van Elteren test. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population.

Posted

Mean

Standard Deviation

Baseline, 6, 12, 18 and 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts

Secondary

Number of Participants With Threshold Hematology Value.

The threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal (ULN) range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal (LLN) range is considered a low threshold value. Hematology laboratory parameters assessed included hemoglobin (Hgb), platelet count, white blood cell count (WBC) and red blood cell (RBC) count. Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population.

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts

Secondary

Number of Participants With Threshold Clinical Chemistry Value.

Clinical chemistry laboratory parameters assessed included albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatinine, glucose, potassium, sodium, total bilirubin, total protein and urea/blood urea nitrogen (BUN). Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population.

Posted

Count of Participants

Participants

Up to 24 Months

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Digital Rectal Examination (DRE)

DRE evaluation was carried out from normal/diffusely enlarged at Baseline to focal abnormalities at any time post-Baseline. DRE was assessed at screening visit, Month 6, 12, 18 , 24 and final assessment is the latest post-Baseline evaluation that was available. Here, participants with focal abnormalities are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population.

Posted

Count of Participants

Participants

6, 12, 18 , 24 months and final assessment

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Qualitative Breast Examination

Qualitative breast examination included palpable breast tissue and nipple tenderness. Here, participants with clinically significant abnormalities for palpable breast tissue and nipple tenderness are summarized. Qualitative breast examination was done at screening visit, Month 6, 12, 18 , 24 and final assessment (latest post-Baseline evaluation that was available). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population.

Posted

Count of Participants

Participants

6, 12, 18 , 24 months and final assessment

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Units	Counts
Participants

Secondary

Number of Participants With Suicidal Ideation and Suicidal Behavior

Suicidality was assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS). It included tabular summaries of suicidal ideation and suicidal behavior questions that were administered. Assessments were carried out at Screening, Month 6, Month 12, and Month 24 (or end of treatment) visits. C-SSRS included Question1-2 were for suicidal ideation Question 1: Passive: wish to be dead, Question 2: Active: Non-specific (no method, intent or plan). Questions 6-10 were for suicidal behavior, Question 6: Preparatory Acts or Behavior, Question 7: any aborted attempt, Question 8: Any interrupted attempts, Question 9: Any non-fatal actual suicide attempt, Question 10: Completed suicide. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

ITT Population.

Posted

Count of Participants

Participants

6, 12, 18 , 24 months and final assessment

ID	Title	Description
OG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
OG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected302 at risk EG0012 events2 affected305 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0007 events7 affected302 at risk EG0010 events0 affected305 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Enteritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pancreatic disorder	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Benign oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events1 affected302 at risk EG0010 events0 affected305 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Syncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected302 at risk EG0010 events0 affected305 at risk
Lacunar infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Brain stem infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Ulnar nerve palsy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected302 at risk EG0013 events3 affected305 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Coronary artery disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Bronchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Appendicitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Dacryocystitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lung infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Bacterial prostatitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Albuminuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Urinary tract inflammation	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected302 at risk EG0010 events0 affected305 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Aortic aneurysm	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Aortic stenosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Infarction	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Ischaemia	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cataract	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Macular hole	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Dacryostenosis acquired	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Mental status changes	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hernia	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Accidental death	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Implant site inflammation	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Thyroid mass	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00046 events30 affected302 at risk EG00145 events37 affected305 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00072 events38 affected302 at risk EG00144 events24 affected305 at risk
Bronchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00011 events11 affected302 at risk EG0018 events8 affected305 at risk
Periodontitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0009 events7 affected302 at risk EG0017 events6 affected305 at risk
Conjunctivitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00010 events10 affected302 at risk EG0012 events2 affected305 at risk
Pharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00012 events10 affected302 at risk EG0012 events2 affected305 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected302 at risk EG0014 events4 affected305 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0013 events3 affected305 at risk
Herpes zoster	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0013 events3 affected305 at risk
Rhinitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0012 events2 affected305 at risk
Influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0013 events2 affected305 at risk
Helicobacter infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0012 events2 affected305 at risk
Dermatophytosis of nail	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0013 events2 affected305 at risk
Epididymitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Hordeolum	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Tinea pedis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Chronic sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Fungal skin infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Gingivitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Pulpitis dental	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Tonsillitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Acute sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Angular cheilitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Dacryocanaliculitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Diverticulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Folliculitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Impetigo	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Laryngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Onychomycosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Otitis media	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Otitis media chronic	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Paronychia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Parotitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Pyoderma	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Skin infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Tinea cruris	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected302 at risk EG0010 events0 affected305 at risk
Tooth abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Tracheitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Trachoma	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Urethritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Wound infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Oral infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Dysentery	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Gingival abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events1 affected305 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Enteritis infectious	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Tinea infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lung infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Myringitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Tinea manuum	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Infected dermal cyst	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0009 events8 affected302 at risk EG00110 events10 affected305 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00013 events11 affected302 at risk EG0018 events7 affected305 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG00113 events13 affected305 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00010 events10 affected302 at risk EG0015 events5 affected305 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected302 at risk EG0017 events6 affected305 at risk
Dental caries	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0008 events8 affected302 at risk EG0013 events3 affected305 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 events5 affected302 at risk EG0016 events5 affected305 at risk
Toothache	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0007 events6 affected302 at risk EG0014 events4 affected305 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected302 at risk EG0013 events3 affected305 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 events4 affected302 at risk EG0013 events3 affected305 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0007 events6 affected302 at risk EG0011 events1 affected305 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected302 at risk EG0013 events3 affected305 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0013 events3 affected305 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0013 events3 affected305 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0014 events4 affected305 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0012 events2 affected305 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0013 events3 affected305 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0011 events1 affected305 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0013 events3 affected305 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0013 events2 affected305 at risk
Enteritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Tongue coated	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Ileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Melaena	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Dental discomfort	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected302 at risk EG0010 events0 affected305 at risk
Appendix disorder	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG00011 events11 affected302 at risk EG00116 events14 affected305 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG00011 events11 affected302 at risk EG0017 events7 affected305 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG00010 events8 affected302 at risk EG0015 events4 affected305 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0017 events7 affected305 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected302 at risk EG0011 events1 affected305 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected302 at risk EG0012 events2 affected305 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected302 at risk EG0011 events1 affected305 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0011 events1 affected305 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0010 events0 affected305 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Bone formation increased	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events1 affected305 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected302 at risk EG0010 events0 affected305 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Sinus tarsi syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected302 at risk EG0010 events0 affected305 at risk
Soft tissue swelling	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG00018 events16 affected302 at risk EG00116 events14 affected305 at risk
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG00012 events10 affected302 at risk EG0016 events5 affected305 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected302 at risk EG0013 events3 affected305 at risk
Lacunar infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0012 events2 affected305 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Sciatica	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Tremor	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Poor quality sleep	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Aphasia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Brain stem infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0013 events1 affected305 at risk
Cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Dizziness postural	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Dysarthria	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Dysgeusia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Dysmetria	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Facial paralysis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hemiparesis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hydrocephalus	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Loss of consciousness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Neuritis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Sensory disturbance	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Syncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Tension headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Vocal cord paresis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Amnestic disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Thalamic infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG00012 events9 affected302 at risk EG0018 events7 affected305 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG00010 events6 affected302 at risk EG0015 events4 affected305 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0007 events7 affected302 at risk EG0011 events1 affected305 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0013 events3 affected305 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0012 events2 affected305 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0013 events3 affected305 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0010 events0 affected305 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Laryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Suffocation feeling	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Vocal cord inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0009 events9 affected302 at risk EG0014 events4 affected305 at risk
Nocturia	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG00110 events8 affected305 at risk
Dysuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected302 at risk EG0013 events3 affected305 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected302 at risk EG0014 events4 affected305 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0015 events5 affected305 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0013 events3 affected305 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0007 events6 affected302 at risk EG0010 events0 affected305 at risk
Renal cyst	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0010 events0 affected305 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Renal impairment	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Incontinence	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Polyuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Proteinuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Renal colic	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Urge incontinence	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Urinary hesitation	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected302 at risk EG00111 events11 affected305 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0007 events7 affected302 at risk EG0014 events4 affected305 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0006 events5 affected302 at risk EG0011 events1 affected305 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0005 events4 affected302 at risk EG0011 events1 affected305 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0012 events2 affected305 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0012 events2 affected305 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected302 at risk EG0010 events0 affected305 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected302 at risk EG0010 events0 affected305 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events1 affected305 at risk
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Urticaria papular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0007 events6 affected302 at risk EG0017 events7 affected305 at risk
Chest discomfort	General disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected302 at risk EG0016 events5 affected305 at risk
Chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0008 events6 affected302 at risk EG0012 events2 affected305 at risk
Asthenia	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected302 at risk EG0012 events2 affected305 at risk
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Oedema peripheral	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Chills	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Feeling abnormal	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Local swelling	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Oedema	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Thirst	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Peripheral swelling	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
General physical health deterioration	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Gait deviation	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Ill-defined disorder	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cataract	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0008 events8 affected302 at risk EG0014 events4 affected305 at risk
Dry eye	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0005 events4 affected302 at risk EG0011 events1 affected305 at risk
Abnormal sensation in eye	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Asthenopia	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Blepharitis	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Eye discharge	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Keratitis	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Vision blurred	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Visual acuity reduced	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Xerophthalmia	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Accommodation disorder	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Borderline glaucoma	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Cataract nuclear	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Conjunctival cyst	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Conjunctival deposit	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Diplopia	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Eye pain	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Eyelid ptosis	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Glaucoma	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Lacrimation decreased	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Macular degeneration	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Ocular hyperaemia	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Posterior capsule opacification	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Presbyopia	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Ocular discomfort	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Ciliary body disorder	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Choroidal neovascularisation	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Iris disorder	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Corneal disorder	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Entropion	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Corneal exfoliation	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Age-related macular degeneration	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected302 at risk EG0011 events1 affected305 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0015 events5 affected305 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0010 events0 affected305 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pharyngeal injury 0 0 1 1 (<1%)	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Bronchitis chemical	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Eyelid contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG00114 events14 affected305 at risk
Ejaculation failure	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0018 events8 affected305 at risk
Sexual dysfunction	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0013 events3 affected305 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Breast enlargement	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events1 affected305 at risk
Ejaculation disorder	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events1 affected305 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Haematospermia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0004 events1 affected302 at risk EG0010 events0 affected305 at risk
Penile swelling	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Retrograde ejaculation	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Scrotal swelling	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Organic erectile dysfunction	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events1 affected305 at risk
Seminal vesicle atrophy	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Gout	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0006 events5 affected302 at risk EG0013 events3 affected305 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0015 events5 affected305 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0014 events4 affected305 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0015 events3 affected305 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0009 events9 affected302 at risk EG0017 events7 affected305 at risk
Hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Varicose vein	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Arteriosclerosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Microangiopathy	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected305 at risk
Intermittent claudication	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Labile blood pressure	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Peripheral circulatory failure	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hot flush	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Insomnia	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0008 events7 affected302 at risk EG0019 events7 affected305 at risk
Libido decreased	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0014 events4 affected305 at risk
Sleep disorder	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected302 at risk EG0011 events1 affected305 at risk
Depression	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Depressed mood	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Disinhibition	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Disorientation	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hallucination	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Mania	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Tobacco abuse	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events1 affected305 at risk
Prostatic specific antigen increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0014 events4 affected305 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Blood glucose increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0013 events3 affected305 at risk
Blood bilirubin increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Blood pressure increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Blood uric acid increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Blood urine present	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Intraocular pressure increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lipids increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Protein urine absent	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Semen volume decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Weight decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Occult blood positive	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Renal scan abnormal	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Residual urine volume increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Helicobacter test positive	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Palpitations	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected302 at risk EG0012 events2 affected305 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Angina unstable	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Arrhythmia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Coronary artery disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected305 at risk
Extrasystoles	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0013 events3 affected305 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected305 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Angiolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0015 events5 affected305 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0013 events3 affected305 at risk
Auditory disorder	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0014 events4 affected305 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected305 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected305 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Cholelithiasis obstructive	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hypothyroidism	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Thyroid mass	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Late onset hypogonadism syndrome	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Hypersensitivity	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected305 at risk
Intraocular lens implant	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected305 at risk

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D001378	Azasteroids
D013260	Steroids, Heterocyclic
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds

ID	Title	Description
BG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
BG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo + Tam 0.2mg	Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	1	302	52	302	203	302
EG001	Dut 0.5 mg + Tam 0.2 mg	Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.	2	305	49	305	208	305