Olmesartan Comparison to Losartan in Hypertensive Subjects | NCT00949884

Label	Type	Description	Intervention Names
Olmesartan	Experimental	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.	Drug: olmesartan medoxomil
Placebo followed by Olmesartan	Placebo Comparator	Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks	Drug: olmesartan medoxomil Drug: Placebo
Losartan	Active Comparator	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks	Drug: losartan potassium

Name	Type	Description	Arm Group Labels	Other Names
olmesartan medoxomil	Drug	Oral tablets, once daily, at either 20mg or 40mg daily.	Olmesartan Placebo followed by Olmesartan

Measure	Description	Time Frame
Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)	The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.	Day 0, Week 8

Measure	Description	Time Frame
Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)	The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

Measure	Description	Time Frame
Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)	The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

PubMed Identifier	Type	Citation	Retractions
22763801	Derived	Punzi HA, Lewin A, Li W, Chavanu KJ. Efficacy/safety of olmesartan medoxomil versus losartan potassium in naive versus previously treated subjects with hypertension. Adv Ther. 2012 Jun;29(6):524-37. doi: 10.1007/s12325-012-0029-5. Epub 2012 Jul 3.

ID	Title	Description
FG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
FG001	Placebo Followed by Olmesartan	Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)

The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Day 0, Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Units	Counts
Participants	OG000384 OG001424 OG002426

Title

Denominators

Categories

Title	Measurements
	OG000-9.8± 0.50 OG001-9.7± 0.45 OG002-7.1± 0.45

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
OG001 OG002	Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.	ANCOVA	The ANCOVA model included treatment as a fixed effect and the baseline DBP as a covariate.	<0.0001		Mean Difference (Final Values)	-2.5	Standard Error of the Mean	0.63	2-Sided	95	-3.8	-1.3				No	Superiority or Other

Secondary

Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)

The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

Posted

Least Squares Mean

Standard Error

mmHg

Day 0, Week 4

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan

Secondary

Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)

The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

Posted

Least Squares Mean

Standard Error

mmHg

Day 0, Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan

Secondary

Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)

The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

Posted

Least Squares Mean

Standard Error

mmHg

Day 0, Week 4

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan

Post-Hoc

Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8

Participants from pre-selected sites had 24-hour ambulatory blood pressure readings collected. Daytime readings were results collected between 8am and 4pm. Nighttime readings were results collected between 10pm and 6am.

Ambulatory Blood Pressure Monitoring (ABPM) Population: All participants in the Efficacy Population that had both valid (technically successful) baseline and Week 8 ambulatory blood pressure monitor data. A technically successful ABPM had at least 23 hours of ABPM data.

Posted

Number

percentage of population

Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)

The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

Posted

Least Squares Mean

Standard Error

mmHg

Week 4, Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan

Other Pre-specified

Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)

The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

Posted

Least Squares Mean

Standard Error

mmHg

Week 4, Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan

Other Pre-specified

Percentage of Participants Achieving Blood Pressure Goals at Week 4

Percentage of participants who achieved the following goals:

Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg

Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.

Posted

Number

percentage of participants analyzed

Week 4

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Percentage of Participants Achieving Blood Pressure Goals at Week 8

Percentage of participants who achieved the following goals:

Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg

Posted

Number

percentage of participants analyzed

Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4

The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 4 ABPM data.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 4

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8

The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 8 ABPM data.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4

In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.

The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 4

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8

In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.

The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4

In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 4

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8

In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 8

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Combined Olmesartan	Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
OG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Other Pre-specified

Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure

The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.

The efficacy population was defined as participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 2

ID	Title	Description
OG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
OG001	Placebo Followed by Olmesartan	Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
OG002	Losartan

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0011 affected52 at risk EG0020 affected469 at risk
Palpitations	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0024 affected469 at risk
Type II hyperlipidaemia	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Hypothyroidism	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Conjunctivitis	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0023 affected469 at risk
Diplopia	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Eye pruritus	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Eye swelling	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0011 affected52 at risk EG0020 affected469 at risk
Vision blurred	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected420 at risk EG0011 affected52 at risk EG0024 affected469 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected420 at risk EG0011 affected52 at risk EG0023 affected469 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Flatulence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected420 at risk EG0012 affected52 at risk EG0029 affected469 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Toothache	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0011 affected52 at risk EG0022 affected469 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0023 affected469 at risk
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Chest discomfort	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0010 affected52 at risk EG0024 affected469 at risk
Feeling cold	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Malaise	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Non-cardiac chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0011 affected52 at risk EG0023 affected469 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Seasonal allergy	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Abscess limb	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Bronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0006 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Cutaneous larva migrans	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Cystitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0011 affected52 at risk EG0021 affected469 at risk
Influenza	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0011 affected52 at risk EG0022 affected469 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0008 affected420 at risk EG0010 affected52 at risk EG00213 affected469 at risk
Oral fungal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Oral herpes	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Pharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0010 affected52 at risk EG0023 affected469 at risk
Tooth abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 affected420 at risk EG0012 affected52 at risk EG00210 affected469 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Viral infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0011 affected52 at risk EG0020 affected469 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0011 affected52 at risk EG0020 affected469 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Alanine aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Blood creatinine abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Blood potassium increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Blood sodium decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Blood sodium increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0011 affected52 at risk EG0022 affected469 at risk
Blood triglycerides increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Blood uric acid increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0004 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Hepatic enzyme increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Liver function test abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Low density lipoprotein increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Lymphocyte morphology abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Neutrophil count increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Protein total increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0011 affected52 at risk EG0020 affected469 at risk
Weight decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
White blood cell count decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Gout	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected420 at risk EG0012 affected52 at risk EG0023 affected469 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0011 affected52 at risk EG0020 affected469 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected420 at risk EG0011 affected52 at risk EG0026 affected469 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00018 affected420 at risk EG0015 affected52 at risk EG00224 affected469 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Migraine	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Nerve compression	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Paraesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0023 affected469 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Sinus headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Somnolence	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Tension headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Dysthymic disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0024 affected469 at risk
Nervousness	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Proteinuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0010 affected52 at risk EG0024 affected469 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0023 affected469 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0024 affected469 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0024 affected469 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0022 affected469 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected420 at risk EG0010 affected52 at risk EG0023 affected469 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0011 affected52 at risk EG0021 affected469 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected420 at risk EG0010 affected52 at risk EG0021 affected469 at risk
Skin odour abnormal	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Sinus operation	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Hot flush	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected420 at risk EG0011 affected52 at risk EG0024 affected469 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk
Venous insufficiency	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected420 at risk EG0010 affected52 at risk EG0020 affected469 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mesa	Arizona	85213	United States

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Title	Description
BG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
BG001	Placebo Followed by Olmesartan	Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
BG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Olmesartan	Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.	0	420	133	420
EG001	Placebo Followed by Olmesartan	Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks	0	52	21	52
EG002	Losartan	Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks	4	469	148	469