A Study of LY2484595 in Patients With High LDL-C or Low H... | NCT01105975

ID	Type	Description	Link
I1V-MC-EIAF	Other Identifier	Eli Lilly and Company

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
30 milligram (mg) LY2484595 monotherapy	Experimental	Drug: LY2484595 Drug: Placebo for Statins
100 mg LY2484595 monotherapy	Experimental	Drug: LY2484595 Drug: Placebo for Statins
500 mg LY2484595 monotherapy	Experimental	Drug: LY2484595 Drug: Placebo for Statins
Placebo	Placebo Comparator	Drug: Placebo for LY2484595 Drug: Placebo for Statins
20 mg Atorvastatin monotherapy	Active Comparator	Drug: Atorvastatin Drug: Placebo for LY2484595
100 mg LY2484595 + 20 mg Atorvastatin	Experimental	Drug: LY2484595 Drug: Atorvastatin
40 mg Simvastatin monotherapy	Active Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY2484595	Drug	Administered daily by mouth for 12 weeks	100 mg LY2484595 + 10 mg Rosuvastatin 100 mg LY2484595 + 20 mg Atorvastatin 100 mg LY2484595 + 40 mg Simvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy	Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.	Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy	Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.	Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo	Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.	Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo

Eligibility Module

Contacts/Locations Module

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

Locations

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.		Fayetteville	Arkansas	72703

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27206939	Derived	Nicholls SJ, Ruotolo G, Brewer HB, Wang MD, Liu L, Willey MB, Deeg MA, Krueger KA, Nissen SE. Evacetrapib alone or in combination with statins lowers lipoprotein(a) and total and small LDL particle concentrations in mildly hypercholesterolemic patients. J Clin Lipidol. 2016 May-Jun;10(3):519-527.e4. doi: 10.1016/j.jacl.2015.11.014. Epub 2015 Dec 18.
26564598

Results Section

Participant Flow Module

ID	Title	Description
FG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
FG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
BG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
BG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
BG003	Placebo	Administered daily by mouth for 12 weeks
BG004	20 mg Atorvastatin Monotherapy	Administered daily by mouth for 12 weeks
BG005	100 mg LY2484595 + 20 mg Atorvastatin	Administered daily by mouth for 12 weeks
BG006	40 mg Simvastatin Monotherapy	Administered daily by mouth for 12 weeks
BG007	100 mg LY2484595 + 40 mg Simvastatin	Administered daily by mouth for 12 weeks
BG008	10 mg Rosuvastatin Monotherapy	Administered daily by mouth for 12 weeks
BG009	100 mg LY2484595 + 10 mg Rosuvastatin	Administered daily by mouth for 12 weeks
BG010	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

Title	Measurements
	BG00058.5± 11.1 BG00158.5± 9.2 BG00258.8± 12.2 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00023 BG00122 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0013 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

United States

Title	Measurements
	BG00022 BG00123 BG002

Weight

Mean

Standard Deviation

kilogram

Title

Denominators

Categories

Title	Measurements
	BG00084.6± 23.2 BG00179.9± 18.3 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kilogram/square meter (kg/m²)

Title

Denominators

Categories

Title	Measurements
	BG00029.8± 7.8 BG00127.6± 5.7 BG002

High-Density Lipoprotein Cholesterol (HDL-C)

Mean

Standard Deviation

milligram/deciliter (mg/dL)

Title

Denominators

Categories

Title	Measurements
	BG00054.7± 12.0 BG00157.0± 14.1 BG002

Low-Density Lipoprotein Cholesterol (LDL-C)

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000143.5± 26.0 BG001148.0± 25.0 BG002

Fasting Triglycerides

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000133.9± 56.6 BG001129.8± 51.7 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

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 HDL-C measurements.

Posted

Least Squares Mean

Standard Error

percent change of mg/dL

Baseline, Week 12

ID	Title	Description
OG000	20 mg Atorvastatin Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 + 20 mg Atorvastatin	Administered daily by mouth for 12 weeks

Units	Counts
Participants	OG00034 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0001.4± 5.7 OG00179.9± 6.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		mixed model repeated measures (MMRM)		<0.001		Mean Difference (Final Values)	78.5			2-Sided	90	64.9	92.1					Superiority or Other

Primary

Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 LDL-C measurements.

Posted

Least Squares Mean

Standard Error

percent change of mg/dL

Baseline, Week 12

ID	Title	Description
OG000	20 mg Atorvastatin Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 + 20 mg Atorvastatin	Administered daily by mouth for 12 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 HDL-C measurements.

Posted

Least Squares Mean

Standard Error

percent change of mg/dL

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks

Secondary

Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 LDL-C measurements.

Posted

Least Squares Mean

Standard Error

percent change of mg/dL

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks

Secondary

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 HDL-C measurements.

Posted

Least Squares Mean

Standard Error

percent change of mg/dL

Baseline, Week 12

ID	Title	Description
OG000	40 mg Simvastatin Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 + 40 mg Simvastatin	Administered daily by mouth for 12 weeks
OG002	10 mg Rosuvastatin Monotherapy	Administered daily by mouth for 12 weeks
OG003	100 mg LY2484595 + 10 mg Rosuvastatin	Administered daily by mouth for 12 weeks

Secondary

Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 LDL-C measurements.

Posted

Least Squares Mean

Standard Error

percent change of mg/dL

Baseline, Week 12

ID	Title	Description
OG000	40 mg Simvastatin Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 + 40 mg Simvastatin	Administered daily by mouth for 12 weeks
OG002	10 mg Rosuvastatin Monotherapy	Administered daily by mouth for 12 weeks
OG003	100 mg LY2484595 + 10 mg Rosuvastatin	Administered daily by mouth for 12 weeks

Secondary

Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State

Participants who were administered LY2484595 and had pharmacokinetics (PK) samples.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms*hour/milliliter (ng*h/mL)

Baseline up to 12 weeks

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	100 mg LY2484595 + 20 mg Atorvastatin	Administered daily by mouth for 12 weeks
OG004	100 mg LY2484595 + 40 mg Simvastatin	Administered daily by mouth for 12 weeks

Secondary

Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 CETP activity measurements.

Posted

Least Squares Mean

Standard Error

percent change of picomoles/mL/minute

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks
OG004	20 mg Atorvastatin Monotherapy

Secondary

Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 CETP mass measurements.

Posted

Least Squares Mean

Standard Error

percent change of micrograms/mL (mcg/mL)

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks
OG004	20 mg Atorvastatin Monotherapy

Secondary

The Number of Episodes of Rashes at Any Time From Baseline Through Week 12

All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.

Participants who took study drug.

Posted

Number

events

Baseline through Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks

Secondary

Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 BP measurements.

Posted

Least Squares Mean

Standard Error

millimeters of mercury (mmHg)

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks
OG004	20 mg Atorvastatin Monotherapy

Secondary

Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 aldosterone measurements.

Posted

Least Squares Mean

Standard Error

nanogram/deciliter (ng/dL)

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks
OG004	20 mg Atorvastatin Monotherapy

Secondary

Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 renin activity measurements.

Posted

Least Squares Mean

Standard Error

nanograms/milliliter/hour (ng/mL/h)

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks
OG004	20 mg Atorvastatin Monotherapy

Secondary

Change From Baseline to 12 Weeks Endpoint in Serum Potassium

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 potassium measurements.

Posted

Least Squares Mean

Standard Error

milliequivalents/Liter

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks
OG004	20 mg Atorvastatin Monotherapy

Secondary

Change From Baseline to 12 Weeks Endpoint in Serum Sodium

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 sodium measurements.

Posted

Least Squares Mean

Standard Error

milliequivalents/Liter

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks
OG004	20 mg Atorvastatin Monotherapy

Secondary

Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and Week 12 bicarbonate measurements.

Posted

Least Squares Mean

Standard Error

milliequivalents/Liter

Baseline, Week 12

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG003	Placebo	Administered daily by mouth for 12 weeks
OG004	20 mg Atorvastatin Monotherapy

Secondary

Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score

EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Participants who had both baseline and at least one post-baseline EQ-5D measurements, last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline up to Week 18

ID	Title	Description
OG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks
OG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	30 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks	0	40	22	40
EG001	100 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks	0	38	25	38
EG002	500 mg LY2484595 Monotherapy	Administered daily by mouth for 12 weeks	1	40	21	40
EG003	Placebo	Administered daily by mouth for 12 weeks	0	38	23	38
EG004	20 mg Atorvastatin Monotherapy	Administered daily by mouth for 12 weeks	0	41	29	41
EG005	100 mg LY2484595 + 20 mg Atorvastatin	Administered daily by mouth for 12 weeks	1	35	22	35
EG006	40 mg Simvastatin Monotherapy	Administered daily by mouth for 12 weeks	1	41	29	41
EG007	100 mg LY2484595 + 40 mg Simvastatin	Administered daily by mouth for 12 weeks	0	40	27	40
EG008	10 mg Rosuvastatin Monotherapy	Administered daily by mouth for 12 weeks	0	39	31	39
EG009	100 mg LY2484595 + 10 mg Rosuvastatin	Administered daily by mouth for 12 weeks	1	41	27	41
EG010	30 mg LY2484595 Monotherapy Follow-Up	30 day follow-up period after last dose of study drug	0	40	7	40
EG011	100 mg LY2484595 Monotherapy Follow-Up	30 day follow-up period after last dose of study drug	0	38	4	38
EG012	500 mg LY2484595 Monotherapy Follow-Up	30 day follow-up period after last dose of study drug	1	40	6	40
EG013	Placebo Follow-Up	30 day follow-up period after last dose of study drug	1	38	8	38
EG014	20 mg Atorvastatin Monotherapy Follow-Up	30 day follow-up period after last dose of study drug	0	41	6	41
EG015	100 mg LY2484595 + 20 mg Atorvastatin Follow-Up	30 day follow-up period after last dose of study drug	0	35	8	35
EG016	40 mg Simvastatin Monotherapy Follow-Up	30 day follow-up period after last dose of study drug	0	41	7	41
EG017	100 mg LY2484595 + 40 mg Simvastatin Follow-Up	30 day follow-up period after last dose of study drug	0	40	4	40
EG018	10 mg Rosuvastatin Monotherapy Follow-Up	30 day follow-up period after last dose of study drug	0	39	6	39
EG019	100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up	30 day follow-up period after last dose of study drug	0	41	5	41

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG0030 events0 affected38 at risk EG0040 events0 affected41 at risk EG0051 events1 affected35 at risk EG0060 events0 affected41 at risk EG0070 events0 affected40 at risk EG0080 events0 affected39 at risk EG0090 events0 affected41 at risk EG0100 events0 affected40 at risk EG0110 events0 affected38 at risk EG0120 events0 affected40 at risk EG0130 events0 affected38 at risk EG0140 events0 affected41 at risk EG0150 events0 affected35 at risk EG0160 events0 affected41 at risk EG0170 events0 affected40 at risk EG0180 events0 affected39 at risk EG0190 events0 affected41 at risk
Influenza	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG0030 events0 affected38 at risk EG0040 events0 affected41 at risk EG0050 events0 affected35 at risk EG0060 events0 affected41 at risk EG0071 events1 affected40 at risk EG0080 events0 affected39 at risk EG0090 events0 affected41 at risk EG0100 events0 affected40 at risk EG0110 events0 affected38 at risk EG0120 events0 affected40 at risk EG0130 events0 affected38 at risk EG0140 events0 affected41 at risk EG0150 events0 affected35 at risk EG0160 events0 affected41 at risk EG0170 events0 affected40 at risk EG0180 events0 affected39 at risk EG0190 events0 affected41 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0022 events1 affected40 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Palpitations	Cardiac disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0012 events2 affected38 at risk EG0020 events0 affected40 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Middle ear inflammation	Ear and labyrinth disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Borderline glaucoma	Eye disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Photopsia	Eye disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Vitreous detachment	Eye disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0021 events1 affected40 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0011 events1 affected38 at risk EG0022 events2 affected40 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0012 events2 affected38 at risk EG0023 events3 affected40 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0002 events2 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Gastritis atrophic	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Gingivitis	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Infrequent bowel movements	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Lip swelling	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0023 events3 affected40 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Periodontitis	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Asthenia	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Fatigue	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Feeling hot	General disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Influenza like illness	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Localised oedema	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Malaise	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Oedema	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Oedema peripheral	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Pyrexia	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Thirst	General disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Allergy to animal	Immune system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Bronchitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Cellulitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Cystitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Ear infection	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Influenza	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0013 events2 affected38 at risk EG0021 events1 affected40 at risk EG003
Laryngitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Localised infection	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0002 events2 affected40 at risk EG0013 events3 affected38 at risk EG0021 events1 affected40 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Otitis media	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Paronychia	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Pneumonia	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Rhinitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Sinusitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Tooth infection	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Tracheitis	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Viral infection	Infections and infestations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Joint sprain	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Open wound	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blood aldosterone decreased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blood bilirubin abnormal	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Blood glucose increased	Investigations	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blood potassium decreased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blood potassium increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blood pressure increased	Investigations	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blood pressure systolic increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blood uric acid abnormal	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Electrocardiogram qt prolonged	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Heart rate irregular	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Liver function test abnormal	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Renin increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Weight increased	Investigations	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Polydipsia	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0022 events2 affected40 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0002 events2 affected40 at risk EG0011 events1 affected38 at risk EG0021 events1 affected40 at risk EG003
Bunion	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0021 events1 affected40 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Amnesia	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Dizziness	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0013 events2 affected38 at risk EG0020 events0 affected40 at risk EG003
Head discomfort	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Headache	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0002 events2 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hemicephalalgia	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Lethargy	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Migraine	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0012 events2 affected38 at risk EG0020 events0 affected40 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Sciatica	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Sensory disturbance	Nervous system disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Affective disorder	Psychiatric disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Agitation	Psychiatric disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0022 events2 affected40 at risk EG003
Mood swings	Psychiatric disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Nervousness	Psychiatric disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Erection increased	Reproductive system and breast disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Ovarian enlargement	Reproductive system and breast disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Polycystic ovaries	Reproductive system and breast disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Heat rash	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0012 events2 affected38 at risk EG0020 events0 affected40 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0021 events1 affected40 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0014 events2 affected38 at risk EG0021 events1 affected40 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hot flush	Vascular disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected38 at risk EG0020 events0 affected40 at risk EG003
Hypertension	Vascular disorders	MedDRA 14	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Hypotension	Vascular disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA 14	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected38 at risk EG0020 events0 affected40 at risk EG003

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D013449	Sulfonamides
D000577	Amides
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D004791	Enzyme Inhibitors
D057847	Lipid Regulating Agents
D045506	Therapeutic Uses

ID	Term
D050171	Dyslipidemias
D006937	Hypercholesterolemia
D050197	Atherosclerosis
D008659	Metabolic Diseases
D052439	Lipid Metabolism Disorders

ID	Term
D009750	Nutritional and Metabolic Diseases
D006949	Hyperlipidemias
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
C568301	evacetrapib
D000069059	Atorvastatin
D019821	Simvastatin
D000068718	Rosuvastatin Calcium
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors