A Study in Participants With Diabetic Kidney Disease | NCT01113801

ID	Type	Description	Link
H9V-MC-GFRF	Other Identifier	Eli Lilly and Company

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
2 mg LY2382770	Experimental	Drug: LY2382770
10 mg LY2382770	Experimental	Drug: LY2382770
50 mg LY2382770	Experimental	Drug: LY2382770

Name	Type	Description	Arm Group Labels	Other Names
LY2382770	Drug	Subcutaneous injection given monthly for 12 months	10 mg LY2382770 2 mg LY2382770 50 mg LY2382770

Measure	Description	Time Frame
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint	Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.	Baseline, 12 months

Measure	Description	Time Frame
Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint	Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.	Baseline, 12 months

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Participants with chronic kidney disease presumed due to diabetes Type 1 or Type 2
Participants with certain levels of kidney function - serum creatinine (SCr) 1.3 to 3.3 mg/dl (115 to 291 micromol/L) inclusive for women and 1.5 to 3.5 mg/dl (132 to 309 micromol/L) inclusive for men, or an estimated glomerular filtration rate (eGFR) 20 to 60 mL/min/1.73 m²
Participants with protein in the urine - 24-hour urine protein/creatinine ratio (PCR) greater than or equal to 800 mg/g (greater than or equal to 91 mg/mmol).
Participants must be on a stable and acceptable dose of an ACE (angiotensin-converting enzyme) inhibitor or an ARB (angiotensin II receptor blocker), or not able to tolerate these medications.

Main Exclusion Criteria:

Female participants who can become pregnant, are pregnant or breastfeeding
Participants who have any of the following medical conditions (the site research staff will discuss these criteria and determine a participant's ability to participate)
- Chronic inflammatory or autoimmune diseases
- Chronic Kidney Disease from causes other than diabetes
- An organ transplant
- Too high a blood pressure
- Viral Hepatitis B or C liver infection, liver cirrhosis, or significant liver disease
- Recent gastrointestinal bleeding
- Acute kidney injury within the 3 months before screening
- Major surgery within 3 months before screening or plan to have it during the study period
- HIV infection- the virus that causes AIDS
- Heart disease that is not considered stable
- Cancer that is too recent or other condition which poses too high a risk for developing cancer
- Required to take drugs that change the immune system

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Phoenix	Arizona	85012

ID	Title	Description
FG000	Placebo	Placebo given subcutaneous (SC) injection monthly for 12 months
FG001	2 mg LY2382770	2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months

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

Title	Measurements
	BG00062.7± 11.31 BG00162.8± 9.20 BG00260.5± 9.05 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00121 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0008 BG00111 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

France

Title	Measurements
	BG0008 BG0019 BG002

Serum Creatinine

Mean

Standard Deviation

milligram/deciliter (mg/dl)

Title

Denominators

Categories

Title	Measurements
	BG0002.209± 0.5917 BG0012.127± 0.5824 BG002

Urine Protein/Creatinine Ratio

Mean

Standard Deviation

gram/gram

Title

Denominators

Categories

Title	Measurements
	BG0003.123± 2.5180 BG0013.266± 2.5723 BG002

Estimated Glomerular Filtration Rate (eGFR)

Mean

Standard Deviation

milliliter/minute/1.73 meter squared

Title

Denominators

Categories

Title	Measurements
	BG00033.835± 11.0568 BG00135.705± 11.7226 BG002

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 in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint

Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.

All randomized participants who received at least 1 dose of drug and had evaluable baseline and post baseline serum creatinine values.

Posted

Least Squares Mean

Standard Error

ln milligrams per deciliter [ln(mg/dL)]

Baseline, 12 months

ID	Title	Description
OG000	Placebo	Placebo given subcutaneous (SC) injection monthly for 12 months
OG001	2 mg LY2382770	2 mg LY2382770 given (SC) injection monthly for 12 months
OG002	10 mg LY2382770	10 mg LY2382770 given SC injection monthly for 12 months
OG003	50 mg LY2382770	50 mg LY2382770 given SC injection monthly for 12 months

Units	Counts
Participants	OG00085 OG00190 OG00291 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.13± 0.019 OG0010.18± 0.019 OG0020.17± 0.019 OG003

Secondary

Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint

All randomized participants who received at least 1 dose of drug and had evaluable urine protein and creatinine ratio values.

Posted

Least Squares Mean

Standard Error

ln grams/grams [ln( g/g)]

Baseline, 12 months

ID	Title	Description
OG000	Placebo	Placebo given subcutaneous (SC) injection monthly for 12 months
OG001	2 mg LY2382770	2 mg LY2382770 given (SC) injection monthly for 12 months
OG002	10 mg LY2382770	10 mg LY2382770 given SC injection monthly for 12 months
OG003	50 mg LY2382770	50 mg LY2382770 given SC injection monthly for 12 months

Secondary

Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval

All randomized participants who received at least 1 dose of drug and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram*hour per milliliter(µg•hr/mL)

Baseline through 12 months (samples collected pre and/or postdose at monthly intervals)

ID	Title	Description
OG000	Placebo	Placebo given subcutaneous (SC) injection monthly for 12 months
OG001	2 mg LY2382770	2 mg LY2382770 given (SC) injection monthly for 12 months
OG002	10 mg LY2382770	10 mg LY2382770 given SC injection monthly for 12 months
OG003	50 mg LY2382770	50 mg LY2382770 given SC injection monthly for 12 months

Secondary

Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months

Analysis of covariance (ANCOVA) model was used with treatment as fixed effects and baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.

All randomized participants who received at least 1 dose of drug.

Posted

Least Squares Mean

Standard Error

ln milligrams per deciliter(mg/dL)/month

Baseline through 12 months

ID	Title	Description
OG000	Placebo	Placebo given subcutaneous (SC) injection monthly for 12 months
OG001	2 mg LY2382770	2 mg LY2382770 given (SC) injection monthly for 12 months
OG002	10 mg LY2382770	10 mg LY2382770 given SC injection monthly for 12 months
OG003	50 mg LY2382770	50 mg LY2382770 given SC injection monthly for 12 months

Secondary

Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months

Analysis of covariance (ANCOVA) model was used with treatment as fixed effects, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) ) log transformed (ln) as covariates.

All randomized participants who received at least 1 dose of drug.

Posted

Least Squares Mean

Standard Error

mL/min/1.73 m²/month

Baseline through 12 months

ID	Title	Description
OG000	Placebo	Placebo given subcutaneous (SC) injection monthly for 12 months
OG001	2 mg LY2382770	2 mg LY2382770 given (SC) injection monthly for 12 months
OG002	10 mg LY2382770	10 mg LY2382770 given SC injection monthly for 12 months
OG003	50 mg LY2382770	50 mg LY2382770 given SC injection monthly for 12 months

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG0032 events2 affected105 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0003 events3 affected103 at risk EG0015 events4 affected105 at risk EG0021 events1 affected103 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0012 events2 affected105 at risk EG0020 events0 affected103 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0013 events2 affected105 at risk EG0022 events2 affected103 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected103 at risk EG0011 events1 affected105 at risk EG0023 events3 affected103 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0010 events0 affected105 at risk EG0024 events4 affected103 at risk EG003
Cardiomegaly	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0012 events2 affected105 at risk EG0022 events2 affected103 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0012 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Cataract	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Corneal oedema	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Macular hole	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Posterior capsule rupture	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Retinal artery occlusion	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Retinal detachment	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0012 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0022 events2 affected103 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0011 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Intestinal polyp	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0012 events2 affected105 at risk EG0020 events0 affected103 at risk EG003
Chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Chills	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Device failure	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Generalised oedema	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Multi-organ failure	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Oedema peripheral	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0022 events2 affected103 at risk EG003
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Sudden death	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Breast abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 events2 affected103 at risk EG0012 events2 affected105 at risk EG0022 events2 affected103 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Device related infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Enterobacter bacteraemia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Furuncle	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Gangrene	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0022 events1 affected103 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Klebsiella sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Orchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected84 at risk EG0020 events0 affected74 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Otitis externa	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0012 events2 affected105 at risk EG0020 events0 affected103 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Staphylococcal abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Streptococcal urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Superinfection bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0003 events3 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0013 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 events1 affected103 at risk EG0012 events2 affected105 at risk EG0020 events0 affected103 at risk EG003
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0012 events2 affected105 at risk EG0021 events1 affected103 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0013 events2 affected105 at risk EG0021 events1 affected103 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Sweat gland tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 events1 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Central nervous system lesion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Cerebellar ischaemia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0013 events3 affected105 at risk EG0021 events1 affected103 at risk EG003
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Diabetic mononeuropathy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Hypoglycaemic coma	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Hypoglycaemic seizure	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0012 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0010 events0 affected105 at risk EG0022 events2 affected103 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Nephropathy	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0012 events2 affected105 at risk EG0021 events1 affected103 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0003 events2 affected103 at risk EG0015 events5 affected105 at risk EG0023 events3 affected103 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected103 at risk EG0014 events4 affected105 at risk EG0022 events2 affected103 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0012 events2 affected105 at risk EG0020 events0 affected103 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected103 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0022 events2 affected103 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0011 events1 affected105 at risk EG0021 events1 affected103 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected103 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected103 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0007 events7 affected103 at risk EG0016 events6 affected105 at risk EG0024 events4 affected103 at risk EG0035 events5 affected105 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected103 at risk EG00110 events8 affected105 at risk EG0028 events8 affected103 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0008 events4 affected103 at risk EG00115 events10 affected105 at risk EG00214 events11 affected103 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected103 at risk EG0018 events7 affected105 at risk EG0025 events5 affected103 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected103 at risk EG0013 events3 affected105 at risk EG0026 events5 affected103 at risk EG003
Fatigue	General disorders	MedDRA 17.0	Systematic Assessment	EG0009 events8 affected103 at risk EG0013 events3 affected105 at risk EG0026 events6 affected103 at risk EG003
Local swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG0007 events7 affected103 at risk EG0013 events2 affected105 at risk EG0022 events1 affected103 at risk EG003
Oedema peripheral	General disorders	MedDRA 17.0	Systematic Assessment	EG00015 events15 affected103 at risk EG00122 events20 affected105 at risk EG00211 events11 affected103 at risk EG003
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected103 at risk EG0018 events8 affected105 at risk EG0024 events4 affected103 at risk EG003
Influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected103 at risk EG0018 events6 affected105 at risk EG0024 events4 affected103 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0008 events8 affected103 at risk EG0016 events6 affected105 at risk EG0025 events3 affected103 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00011 events10 affected103 at risk EG00111 events11 affected105 at risk EG00216 events13 affected103 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0006 events6 affected103 at risk EG00111 events10 affected105 at risk EG0022 events1 affected103 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected103 at risk EG0016 events6 affected105 at risk EG0028 events8 affected103 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG00016 events10 affected103 at risk EG00120 events13 affected105 at risk EG00225 events9 affected103 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0005 events4 affected103 at risk EG0018 events7 affected105 at risk EG0027 events6 affected103 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0006 events6 affected103 at risk EG0018 events8 affected105 at risk EG0029 events9 affected103 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 events3 affected103 at risk EG0016 events6 affected105 at risk EG0025 events4 affected103 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected103 at risk EG00111 events8 affected105 at risk EG0024 events4 affected103 at risk EG003
Dizziness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0009 events8 affected103 at risk EG0019 events8 affected105 at risk EG0024 events4 affected103 at risk EG003
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0005 events3 affected103 at risk EG0017 events7 affected105 at risk EG0029 events8 affected103 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected21 at risk EG0020 events0 affected29 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected21 at risk EG0020 events0 affected29 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected21 at risk EG0020 events0 affected29 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected103 at risk EG0017 events7 affected105 at risk EG0026 events5 affected103 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 events4 affected103 at risk EG0014 events4 affected105 at risk EG0022 events2 affected103 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0006 events6 affected103 at risk EG0016 events6 affected105 at risk EG0029 events9 affected103 at risk EG003

ID	Term
D003928	Diabetic Nephropathies
D051436	Renal Insufficiency, Chronic
D007676	Kidney Failure, Chronic
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

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
D051437	Renal Insufficiency
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Placebo	Placebo given subcutaneous (SC) injection monthly for 12 months
BG001	2 mg LY2382770	2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
BG002	10 mg LY2382770	10 mg LY2382770 given SC injection monthly for 12 months
BG003	50 mg LY2382770	50 mg LY2382770 given SC injection monthly for 12 months
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo given subcutaneous (SC) injection monthly for 12 months	39	103	57	103
EG001	2 mg LY2382770	2 mg LY2382770 given (SC) injection monthly for 12 months	44	105	67	105
EG002	10 mg LY2382770	10 mg LY2382770 given SC injection monthly for 12 months	37	103	62	103
EG003	50 mg LY2382770	50 mg LY2382770 given SC injection monthly for 12 months	41	105	62	105