Safety and Efficacy of Different Oral Doses of BAY94-8862... | NCT01874431

NCT01874431

ID	Type	Description	Link
2012-004179-38	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Finerenone (BAY94-8862) (1.25 mg)	Experimental	1.25 mg dose oral once daily for 90 days	Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(2.5 mg)	Experimental	2.5 mg dose oral once daily for 90 days	Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(5 mg)	Experimental	5 mg dose oral once daily for 90 days	Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(7.5 mg)	Experimental	7.5 mg dose oral once daily for 90 days	Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862) (10 mg)	Experimental	10 mg dose oral once daily for 90 days	Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862) (15 mg)	Experimental	15 mg dose oral once daily for 90 days

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Finerenone (BAY94-8862)	Drug		Finerenone (BAY94-8862) (1.25 mg) Finerenone (BAY94-8862) (10 mg) Finerenone (BAY94-8862) (15 mg) Finerenone (BAY94-8862)(2.5 mg) Finerenone (BAY94-8862)(20 mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ratio of UACR at Day 90 to UACR at Baseline	Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.	Baseline and Day 90±2

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Day 90 in Serum Potassium		Baseline and Day 90±2
Change From Baseline to Day 90 in eGFR	An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.
Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria
- are on oral antidiabetics and / or insulin,
- have a documented fasting glucose >/= 7.0 mmol/L in the medical history,
- have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
- have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit
Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:
- Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g ( >/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
- Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²
Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

Non-diabetic renal disease
Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean supine SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Dialysis for acute renal failure within the previous 6 months prior to the run-in visit

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35294	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26325557	Result	Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.
31583611

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Finerenone (BAY94-8862) (1.25 mg)	1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
FG001	Finerenone (BAY94-8862) (2.5 mg)	2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Finerenone (BAY94-8862) (1.25 mg)	1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
BG001	Finerenone (BAY94-8862) (2.5 mg)	2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
BG002	Finerenone (BAY94-8862) (5 mg)	5 mg BAY94-8862 tablet once daily in the morning for 90 days.
BG003	Finerenone (BAY94-8862) (7.5 mg)	7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
BG004	Finerenone (BAY94-8862) (10 mg)	10 mg BAY94-8862 tablet once daily in the morning for 90 days.
BG005	Finerenone (BAY94-8862) (15 mg)	15 mg BAY94-8862 tablet once daily in the morning for 90 days.
BG006	Finerenone (BAY94-8862) (20 mg)	20 mg BAY94-8862 tablet once daily in the morning for 90 days
BG007	Placebo	Placebo tablet once daily in the morning for 90 days.
BG008	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00096 ParticipantsBG00192 ParticipantsBG002100 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00096 ParticipantsBG00192 ParticipantsBG002

Baseline UACR

Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was determined from 3 first morning void samples taken on 3 consecutive days.

Mean

Standard Deviation

g/kg

Title	Denominators	Categories
	ParticipantsBG00096 ParticipantsBG00192 ParticipantsBG002

Baseline potassium

Mean

Standard Deviation

mmol/L

Title	Denominators	Categories
	ParticipantsBG00096 ParticipantsBG00192 ParticipantsBG002

Baseline eGFR

An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Mean

Standard Deviation

mL/min/1.73m^2

Title	Denominators	Categories
	ParticipantsBG00096 ParticipantsBG00192 ParticipantsBG002

Baseline KDQOL-36 domain score (Effects of Kidney Disease)

The Kidney Disease QOL [KDQOL]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (serve problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" subscore was analyzed.

Participants with valid data for this baseline characteristic

Mean

Standard Deviation

Scores on a scale

Title	Denominators	Categories
	ParticipantsBG00095 ParticipantsBG001

Baseline EQ-5D scores (EQ5D - Visual Analog Scale)

EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state).

Participants with valid data for this baseline characteristic

Mean

Standard Deviation

Score on a scale

Title	Denominators	Categories
	ParticipantsBG00096 ParticipantsBG001

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

Ratio of UACR at Day 90 to UACR at Baseline

Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.

Full analysis set (FAS): included all participants of the SAF who had baseline and at least one post-baseline UACR value.

Posted

Least Squares Mean

90% Confidence Interval

Ratio

Baseline and Day 90±2

ID	Title	Description
OG000	Finerenone (BAY94-8862) (1.25 mg)	1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
OG001	Finerenone (BAY94-8862) (2.5 mg)	2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG002	Finerenone (BAY94-8862) (5 mg)	5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG003	Finerenone (BAY94-8862) (7.5 mg)	7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG004	Finerenone (BAY94-8862) (10 mg)	10 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG005	Finerenone (BAY94-8862) (15 mg)	15 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG006	Finerenone (BAY94-8862) (20 mg)	20 mg BAY94-8862 tablet once daily in the morning for 90 days
OG007	Placebo	Placebo tablet once daily in the morning for 90 days.

Units	Counts
Participants	OG00096 OG00192 OG00298 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.869± 0.772(0.772 to 0.979) OG0010.89± 0.786(0.786 to 1.009) OG0020.824± 0.73(0.73 to 0.929)

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 OG007	To demonstrate a dose-dependent effect of finerenone, an analysis of covariance (ANCOVA) with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a last-observation carried-forward (LOCF) method for missing observations.	t-test, 1 sided		0.1973		Least square mean ratio	0.926			2-Sided	90	0.799	1.074					Other

Secondary

Change From Baseline to Day 90 in Serum Potassium

Participants in SAF with valid data for this endpoint

Posted

Least Squares Mean

95% Confidence Interval

millimole per liter

Baseline and Day 90±2

ID	Title	Description
OG000	Finerenone (BAY94-8862) (1.25 mg)	1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
OG001	Finerenone (BAY94-8862) (2.5 mg)	2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG002	Finerenone (BAY94-8862) (5 mg)	5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG003	Finerenone (BAY94-8862) (7.5 mg)	7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG004	Finerenone (BAY94-8862) (10 mg)	10 mg BAY94-8862 tablet once daily in the morning for 90 days.

Secondary

Change From Baseline to Day 90 in eGFR

An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Participants in SAF with valid data for this endpoint

Posted

Least Squares Mean

95% Confidence Interval

mL/min/1.73m^2

Baseline and Day 90±2

ID	Title	Description
OG000	Finerenone (BAY94-8862) (1.25 mg)	1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
OG001	Finerenone (BAY94-8862) (2.5 mg)	2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG002	Finerenone (BAY94-8862) (5 mg)	5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG003	Finerenone (BAY94-8862) (7.5 mg)	7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG004

Secondary

Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease)

The Kidney Disease QOL [KDQOL]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" subscore was analyzed.

Participants in FAS with valid data for this endpoint

Posted

Least Squares Mean

95% Confidence Interval

scores on a scale

Baseline and Day 90±2

ID	Title	Description
OG000	Finerenone (BAY94-8862) (1.25 mg)	1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
OG001	Finerenone (BAY94-8862) (2.5 mg)	2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG002	Finerenone (BAY94-8862) (5 mg)	5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG003	Finerenone (BAY94-8862) (7.5 mg)

Secondary

Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale)

Participants in FAS with valid data for this endpoint

Posted

Least Squares Mean

95% Confidence Interval

scores on a scale

Baseline and Day 90±2

ID	Title	Description
OG000	Finerenone (BAY94-8862) (1.25 mg)	1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
OG001	Finerenone (BAY94-8862) (2.5 mg)	2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG002	Finerenone (BAY94-8862) (5 mg)	5 mg BAY94-8862 tablet once daily in the morning for 90 days.
OG003

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Finerenone (BAY94-8862) (1.25 mg)	1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days	0	96	5	96	14	96
EG001	Finerenone (BAY94-8862)(2.5 mg)	2.5 mg BAY94-8862 tablet once daily in the morning for 90 days	0	92	3	92	7	92
EG002	Finerenone (BAY94-8862)(5 mg)	5 mg BAY94-8862 tablet once daily in the morning for 90 days	0	100	7	100	13	100
EG003	Finerenone (BAY94-8862)(7.5 mg)	7.5 mg BAY94-8862 tablet once daily in the morning for 90 days	0	97	8	97	11	97
EG004	Finerenone (BAY94-8862)(10 mg)	10 mg BAY94-8862 tablet once daily in the morning for 90 days	0	98	2	98	10	98
EG005	Finerenone (BAY94-8862)(15 mg)	15 mg BAY94-8862 tablet once daily in the morning for 90 days	1	125	6	125	11	125
EG006	Finerenone (BAY94-8862)(20 mg)	20 mg BAY94-8862 tablet once daily in the morning for 90 days	0	119	4	119	12	119
EG007	Placebo	Placebo tablet once daily in the morning for 90 days	1	94	3	94	8	94

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG0030 events0 affected97 at risk EG0041 events1 affected98 at risk EG0050 events0 affected125 at risk EG0060 events0 affected119 at risk EG0070 events0 affected94 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0021 events1 affected100 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Angle closure glaucoma	Eye disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0022 events1 affected100 at risk EG003
Local swelling	General disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected92 at risk EG0020 events0 affected100 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0021 events1 affected100 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Urosepsis	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0021 events1 affected100 at risk EG003
Blood potassium increased	Investigations	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected92 at risk EG0020 events0 affected100 at risk EG003
Pancreatic enzymes increased	Investigations	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected92 at risk EG0020 events0 affected100 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (17.0)	Non-systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected92 at risk EG0021 events1 affected100 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0021 events1 affected100 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Non-systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Cerebrovascular disorder	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0021 events1 affected100 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0021 events1 affected100 at risk EG003
Syncope	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Coronary artery bypass	Surgical and medical procedures	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Toe amputation	Surgical and medical procedures	MedDRA (17.0)	Non-systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected92 at risk EG0020 events0 affected100 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0005 events5 affected96 at risk EG0012 events2 affected92 at risk EG0024 events4 affected100 at risk EG0032 events2 affected97 at risk EG0042 events2 affected98 at risk EG0054 events3 affected125 at risk EG0065 events5 affected119 at risk EG0072 events2 affected94 at risk
Nasopharyngitis	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0007 events7 affected96 at risk EG0014 events4 affected92 at risk EG0028 events8 affected100 at risk EG003
Dizziness	Nervous system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0006 events6 affected96 at risk EG0011 events1 affected92 at risk EG0023 events3 affected100 at risk EG003

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases