Safety and Efficacy of BGS649 in Male Obese Subjects With... | NCT02730169

Label	Type	Description	Intervention Names
BGS649 0.1 mg	Experimental	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules)	Drug: BGS649
BGS649 0.3 mg	Experimental	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules)	Drug: BGS649
BGS649 1.0 mg	Experimental	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules)	Drug: BGS649
Placebo	Placebo Comparator	Placebo weekly (3 indistinguishable placebo capsules)	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BGS649	Drug	Capsules were taken weekly for a maximum of 24 weeks	BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg

Measure	Description	Time Frame
Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment	Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.	24 weeks of treatment

Measure	Description	Time Frame
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24	Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range.	Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Measure	Description	Time Frame
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.	PSA was measured alongside other clinical chemistry parameters at screening, baseline, Visits 1 through 8 and at follow-up.	Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Mean (SD) Change From Baseline in Haematocrit to Week 24.

Name	Affiliation	Role
Hugh Jones	Barnsley Hospital NHS Foundation Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mereo Research Site		Birmingham	Alabama		United States
Mereo Research Site

PubMed Identifier	Type	Citation	Retractions
37579053	Derived	Jones TH, Dobs AS, Randeva H, Moore W, Parkin JM. Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial. Eur J Endocrinol. 2023 Sep 1;189(3):297-308. doi: 10.1093/ejendo/lvad099.

ID	Title	Description
FG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
FG001	BGS649 0.3 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 10, 2017	Sep 8, 2020

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

Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment

Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.

ITT Population

Posted

Count of Participants

Participants

24 weeks of treatment

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

Units	Counts
Participants	OG00067 OG00165 OG00267 OG003

Title

Denominators

Categories

Title	Measurements
	OG00059 OG00162 OG00263 OG003

Secondary

The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24

Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range.

ITT Population

Posted

Count of Participants

Participants

Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo

Secondary

Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24

Testosterone overshoot was defined as total testosterone above 1000 ng/dL (35 nmol/L). Samples were collected in the morning before 11 am pre dose.

ITT population

Posted

Count of Participants

Participants

Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo

Secondary

Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.

Normalized total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels >1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.

ITT Population

Posted

Count of Participants

Participants

24 weeks of treatment

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003

Secondary

Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24.

LH was measured at screening, baseline. The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.

ITT Population

Posted

Mean

Standard Deviation

mIU/mL

Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

Secondary

Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24.

FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.

ITT Population

Posted

Mean

Standard Deviation

mIU/mL

Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

Secondary

Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks.

Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.

PK population

Posted

Geometric Mean

95% Confidence Interval

ng/mL

Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

Units	Counts

Secondary

Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks.

Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.

PK population

Posted

Geometric Mean

95% Confidence Interval

ng/mL

Week 24 and week 24/End of treatment

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

Units	Counts

Other Pre-specified

Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24.

PSA was measured alongside other clinical chemistry parameters at screening, baseline, Visits 1 through 8 and at follow-up.

Safety Population

Posted

Mean

Standard Deviation

ug/L

Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

Other Pre-specified

Mean (SD) Change From Baseline in Haematocrit to Week 24.

Haematocrit was measured alongside other haematology parameters at screening, baseline, Visits 1 through 8 and at follow-up.

Safety Population

Posted

Mean

Standard Deviation

Ratio

Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

Other Pre-specified

Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24.

Summary of DEXA Scan T-score at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. DEXA T-score was calculated based on actual measured bone density value and compared to a standard reference range for healthy young adult men.

A bone density scan compares bone density with the bone density expected for a young healthy adult or a healthy adult of the same age, gender and ethnicity. The difference is calculated as a standard deviation (SD) score. The measures between the bone density and the expected value of a young healthy adult is known as the T score.

The World Health Organization (WHO) classifies T scores as follows:

above -1 SD is normal
between -1 and -2.5 SD is defined as mildly reduced bone mineral density (BMD) compared with peak bone mass (PBM)
at or below -2.5 SD is defined as osteoporosis

Safety Population

Posted

Mean

Standard Deviation

T-score

Screening to Week 24

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

Other Pre-specified

Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24

Summary of DEXA scan density at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. Bone density was evaluated with standard procedure for Hologic and General Electric Lunar scanners.

Safety Population

Posted

Mean

Standard Deviation

g/cm^2

Screening to Week 24

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

Other Pre-specified

Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24.

Descriptive statistics were presented for the following bone turnover marker parameters: type I collagen C-telopeptides, procollagen 1 N-terminal propeptide, osteocalcin, and bone specific alkaline phosphatase.

ITT Population. Discrepancies in numbers from the progress flow are due to missing samples either at baseline or wk 24/EOT.

Posted

Mean

Standard Deviation

ug/L

Screening to Week 24

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo

Other Pre-specified

Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24.

Change from baseline in bone specific alkaline phosphatase at week 24 measured in U/L

ITT population on all available samples and including all wk 24 and end-of-treatment visit data.

Posted

Mean

Standard Deviation

U/L

24 weeks

ID	Title	Description
OG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
OG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0004 events3 affected67 at risk EG0014 events3 affected66 at risk EG0022 events2 affected67 at risk EG0035 events5 affected71 at risk
Nasopharyngitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0012 events2 affected66 at risk EG0021 events1 affected67 at risk EG003
Sinusitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Influenza	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0012 events2 affected66 at risk EG0020 events0 affected67 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Pneumonia	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Sepsis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Tooth infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Bacterial prostatitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Bronchitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Ear infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Folliculitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Furuncle	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Gastritis viral	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Oral herpes	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Otitis externa	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Otitis media	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Otitis media acute	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Rash pustular	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0022 events1 affected67 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Tinea pedis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Haematocrit increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0002 events1 affected67 at risk EG0015 events4 affected66 at risk EG0026 events5 affected67 at risk EG003
Prostatic specific antigen increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0011 events1 affected66 at risk EG0024 events4 affected67 at risk EG003
Blood triglycerides increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0012 events2 affected66 at risk EG0021 events1 affected67 at risk EG003
Weight increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0022 events2 affected67 at risk EG003
Blood creatinine increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Blood pressure increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0022 events2 affected67 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Blood glucose increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Blood insulin increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Blood pressure decreased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Blood prolactin increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Blood urine present	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
C-reactive protein increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Heart rate irregular	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0003 events3 affected67 at risk EG0013 events3 affected66 at risk EG0021 events1 affected67 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0012 events2 affected66 at risk EG0022 events2 affected67 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0012 events2 affected66 at risk EG0020 events0 affected67 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0023 events3 affected67 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0023 events1 affected67 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Headache	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0008 events7 affected67 at risk EG0014 events3 affected66 at risk EG0024 events4 affected67 at risk EG003
Dizziness	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0003 events3 affected67 at risk EG0010 events0 affected66 at risk EG0022 events2 affected67 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Syncope	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Central nervous system lesion	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Complex regional pain syndrome	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Lethargy	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Migraine	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Presyncope	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Primary headache associated with sexual activity	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Sensory loss	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Tremor	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0012 events2 affected66 at risk EG0021 events1 affected67 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0022 events1 affected67 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Fatigue	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0014 events4 affected66 at risk EG0021 events1 affected67 at risk EG003
Chest pain	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Oedema peripheral	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Influenza like illness	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Asthenia	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Chest discomfort	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Cyst	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Energy increased	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Feeling hot	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Oedema	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Pain	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Pyrexia	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected66 at risk EG0022 events2 affected67 at risk EG003
Depression	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0013 events3 affected66 at risk EG0020 events0 affected67 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Irritability	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Agitation	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Apathy	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Euphoric mood	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Loss of libido	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Mood altered	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Back injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0012 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0022 events2 affected67 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0022 events2 affected67 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0012 events2 affected66 at risk EG0021 events1 affected67 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0022 events2 affected67 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events1 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0022 events2 affected67 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Androgenetic alopecia	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Penile ulceration	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Seborrhoea	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0023 events3 affected67 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0022 events1 affected67 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Bladder outlet obstruction	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0021 events1 affected67 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Erection increased	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Prostatic mass	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Prostatomegaly	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Spontaneous penile erection	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Testicular hypertrophy	Reproductive system and breast disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected67 at risk EG0012 events2 affected66 at risk EG0025 events5 affected67 at risk EG003
Haematoma	Vascular disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Hot flush	Vascular disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Polycythaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0003 events3 affected67 at risk EG0012 events2 affected66 at risk EG0020 events0 affected67 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Cyanosis	Cardiac disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Extrasystoles	Cardiac disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Left ventricular hypertrophy	Cardiac disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Dry eye	Eye disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0022 events2 affected67 at risk EG003
Blepharitis	Eye disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

ID	Title	Description
BG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks
BG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BGS649 0.1 mg	BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	67	2	67	37	67
EG001	BGS649 0.3 mg	BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	66	2	66	39	66
EG002	BGS649 1.0 mg	BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	67	5	67	47	67
EG003	Placebo	Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks	71	5	71	41	71

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Postoperative wound infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG0031 events1 affected71 at risk
Arthritis infective	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0024 events1 affected67 at risk EG003
Pneumonia	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Sepsis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Chest pain	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Syncope	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected66 at risk EG0020 events0 affected67 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected66 at risk EG0021 events1 affected67 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected66 at risk EG0020 events0 affected67 at risk EG003