Assessment of Efficacy and Safety of Olmesartan Medoxomil... | NCT00151775

Description Module

Detailed Description

This was a randomized, multicenter, double-blind, parallel-group, prospective dose-ranging study in subjects 1 to 16 years of age with hypertension. Subjects were enrolled into 1 of 3 cohorts based on age and race. Subjects 6 to 16 years of age were enrolled into Cohort A. Subjects enrolled into Cohort A were stratified by age with approximately half aged 6 to 12 years and the remainder aged 13 to 16 years. Approximately 15% of the subjects in Cohort A were to be Black or of African descent. When a minimum of 28 Black subjects were randomized into Cohort A, enrollment in Cohort B was started. Black subjects only, 6 to 16 years of age, were enrolled into Cohort B. For Cohorts A and B body weight of any patient was >=20Kg. Seated systolic blood pressure (SeSBP) was >=95th percentile for gender and height-for-age, or >=90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension. Patients with symptomatic hypertension requiring immediate established therapy, or who are above 2 standard deviations (SD) above the 99th percentile did not participate in the study.

Subjects 1 to 5 years of age were enrolled into Cohort C regardless of race. Body weight of any patient was >=5Kg. SeSBP was >=95th percentile for gender and height-for-age, or >=90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension. Patients on stable doses of concomitant antihypertensive agents including calcium channel blockers and/or diuretics only are permitted to enroll. Patients with symptomatic hypertension requiring immediate established therapy, or who are above 2 SD above the 99th percentile did not participate in the study.

The study comprised four periods. Period I was a wash-out period from Week -1 to randomization. Subjects were randomized to treatment sequences carried through the remainder of the study. Period II was a three-week, double-blind, dose-ranging period for Cohorts A and B, beginning at Day 1 and ending at the end of Week 3. In Cohorts A and B, subjects received either low-dose or high-dose olmesartan (OM) once daily. In Cohort C, Period II was an open-label OM treatment period where all subjects received 0.3 mg/kg OM per day. Period III was a double-blind, placebo-controlled withdrawal period beginning at Week 4 and ending after 1 or 2 weeks, depending on the seated blood pressure measurement at each weekly study visit. Subjects either continued their Period II OM regimen or switched to placebo based on the initial randomization scheme. Period IV was a 46-week open-label extension period.

Label	Type	Description	Intervention Names
Period 2	Experimental	For Cohorts A and B, olmesartan medoxomil suspension 2.5 mg to 40 mg in patients 6-16 years old, depending on weight. For Cohort C, olmesartan medoxomil suspension 0.3 mg/kg to in patients 1-5 years old.	Drug: olmesartan medoxomil
Period 3	Experimental	Cohorts A, B, C - olmesartan medoxomil suspension or placebo taken once daily. Olmesartan medoxomil dose continued as in previous period.	Drug: olmesartan medoxomil Drug: placebo
Period 4	Experimental	Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg	Drug: olmesartan medoxomil

Name	Type	Description	Arm Group Labels	Other Names
olmesartan medoxomil	Drug	Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension. Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily

Measure	Description	Time Frame
Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)	The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.	Day 0 to 3 weeks
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)	Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.	Day 0 (baseline) to 3 weeks

Measure	Description	Time Frame
Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3	Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.

ID	Title	Description
FG000	Cohort A: High Dose OM in Periods 2, 3	Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).

Arm/Group Information

ID	Title	Description
BG000	Cohort A: High Dose OM	Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
BG001	Cohort A: Low Dose OM	Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
BG002	Cohort B: High Dose OM	Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
BG003	Cohort B: Low Dose OM	Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
BG004	Cohort C: OM (Olmesartan Medoxomil)	Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
BG005	Total	Total of all reporting groups

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

Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)

The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.

The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.

Posted

Least Squares Mean

Standard Error

mm Hg

Day 0 to 3 weeks

ID	Title	Description
OG000	Cohort A	Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
OG001	Cohort B	Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
OG002	Cohorts A + B	Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.

Units	Counts
Participants	OG000190 OG001112 OG002302

Title

Denominators

Categories

Non-weight adjusted dosage

Title	Measurements
	OG000-0.69± 0.202 OG001-0.85± 0.282 OG002-0.75± 0.165

Weight adjusted dosage

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	Non-weight adjusted dosage	Regression, Linear		0.0008							95						No	Superiority or Other
OG000	Weight adjusted dosage	Regression, Linear

Primary

Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)

Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.

The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used

Posted

Mean

Standard Deviation

mm Hg

Day 0 (baseline) to 3 weeks

ID	Title	Description
OG000	Cohort A: Low Dose OM	Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
OG001	Cohort A: High Dose OM	Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).

Secondary

Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.

Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.

Posted

Mean

Standard Deviation

mm Hg

Week 3 (period 3 baseline) to week 5 (end of Period 3)

ID	Title	Description
OG000	Cohort A: OM Period 3	Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
OG001	Cohort A: Placebo Period 3	Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.

Secondary

Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Posted

Mean

Standard Deviation

mm Hg

Week 3 (period 3 baseline) to week 5 (end of Period 3)

ID	Title	Description
OG000	Cohort C: OM Period 3	Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group continued on its Period 2 olmesartan dose of 0.3 mg/kg.
OG001	Cohort C: Placebo Period 3	Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group was switched from its Period 2 olmesartan dose of 0.3 mg/kg to placebo.

Units

Secondary

Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)

Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.

Intent to treat population includes participants with at least one visit in Period 4.

Posted

Mean

Standard Deviation

mm Hg

Day 0 to week 51 (end of study)

ID	Title	Description
OG000	Cohort A: Period 4 Open-label OM	All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
OG001	Cohort B: Period 4 Open-label OM	All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Secondary

Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)

Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.

57=the number of participants who received medication in Period 4

Posted

Mean

Standard Deviation

mm Hg

Day 0 to week 51 week (end of study)

ID	Title	Description
OG000	Cohort C: OM (Olmesartan Medoxomil)	Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort A: Period 2 High Dose OM	For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.	2	95	47	95
EG001	Cohort A: Period 2 Low Dose OM	For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.	1	95	46	95
EG002	Cohort A: Period 3 OM High Dose Continued	The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.	0	48	15	48
EG003	Cohort A: Period 3 Placebo From High Dose	Placebo was given instead of the previous high dose of olmesartan	0	45	6	45
EG004	Cohort A: Period 3 OM Low Dose Continued	The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.	0	45	9	45
EG005	Cohort A: Period 3 Placebo From Low Dose	Placebo was given instead of the previous low dose of olmesartan	0	44	6	44
EG006	Cohort A: Period 4 Open-label OM	10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.	20	179	128	178
EG007	Cohort B: Period 2 High Dose OM	For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.	0	56	9	56
EG008	Cohort B: Period 2 Low Dose OM	For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.	0	56	12	56
EG009	Cohort B: Period 3 OM High Dose Continued	The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.	1	26	4	26
EG010	Cohort B: Period 3 Placebo From High Dose	Placebo was given instead of the previous high dose of olmesartan	0	28	1	28
EG011	Cohort B: Period 3 OM Low Dose Continued	The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.	0	27	2	27
EG012	Cohort B: Period 3 Placebo From Low Dose	Placebo was given instead of the previous low dose of olmesartan	0	26	1	26
EG013	Cohort B: Period 4 Open-label OM	10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.	7	104	56	103
EG014	Cohort C: Period 2 Open-label OM	The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age.	0	59	12	59
EG015	Cohort C: Period 3 OM Dose Continued	The 0.3 mg/kg dose of OM was continued for these participants	0	29	4	29
EG016	Cohort C: Period 3 Placebo	The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.	0	29	8	28
EG017	Cohort C: Period 4 Open-label OM	Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.	6	57	46	57

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abcess limb	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG0030 events0 affected45 at risk EG0040 events0 affected45 at risk EG0050 events0 affected44 at risk EG0060 events0 affected179 at risk EG0070 events0 affected56 at risk EG0080 events0 affected56 at risk EG0090 events0 affected26 at risk EG0100 events0 affected28 at risk EG0110 events0 affected27 at risk EG0120 events0 affected26 at risk EG0131 affected104 at risk EG0140 events0 affected59 at risk EG0150 events0 affected29 at risk EG0160 events0 affected29 at risk EG0170 events0 affected57 at risk
Anasarca	General disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Bronchitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Broncopneumonia	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Coarctation of the aorta	Congenital, familial and genetic disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Depression	Psychiatric disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0011 affected95 at risk EG0020 events0 affected48 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Eye hemorrhage	Eye disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Hypoproteinemia	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Laparoscopy	Investigations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Metabolic disorder	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Ophthalmoplegia	Eye disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Peritonitis	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Pneumonia	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Sinusitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Upper respiratory infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0003 affected95 at risk EG0015 affected95 at risk EG0020 events0 affected48 at risk EG0030 events0 affected45 at risk EG0040 events0 affected45 at risk EG0050 events0 affected44 at risk EG00610 affected178 at risk EG0071 affected56 at risk EG0080 events0 affected56 at risk EG0090 events0 affected26 at risk EG0100 events0 affected28 at risk EG0110 events0 affected27 at risk EG0120 events0 affected26 at risk EG0139 affected103 at risk EG0140 events0 affected59 at risk EG0150 events0 affected29 at risk EG0160 events0 affected28 at risk EG0170 events0 affected57 at risk
Pyrexia	General disorders	MedDRA (8.1)	Systematic Assessment	EG0004 affected95 at risk EG0014 affected95 at risk EG0023 affected48 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected95 at risk EG0014 affected95 at risk EG0020 events0 affected48 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0007 affected95 at risk EG0014 affected95 at risk EG0020 events0 affected48 at risk EG003
Dizziness	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG0009 affected95 at risk EG0012 affected95 at risk EG0020 events0 affected48 at risk EG003
Headache	Nervous system disorders	MedDRA (8.1)	Systematic Assessment	EG00014 affected95 at risk EG0017 affected95 at risk EG0024 affected48 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected95 at risk EG0016 affected95 at risk EG0022 affected48 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected95 at risk EG0013 affected95 at risk EG0023 affected48 at risk EG003
Influenza	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0001 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0004 affected95 at risk EG0012 affected95 at risk EG0020 events0 affected48 at risk EG003
Blood urea increased	Investigations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0023 affected48 at risk EG003
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0002 affected95 at risk EG0013 affected95 at risk EG0020 events0 affected48 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0012 affected95 at risk EG0020 events0 affected48 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (8.1)	Systematic Assessment	EG0001 affected95 at risk EG0012 affected95 at risk EG0020 events0 affected48 at risk EG003
Otitis media acute	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Tonsilitis	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Viral infection	Infections and infestations	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0012 affected95 at risk EG0020 events0 affected48 at risk EG003
Pseudohyperkalemia	Metabolism and nutrition disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Proteinurea	Renal and urinary disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003
Rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Systematic Assessment	EG0000 events0 affected95 at risk EG0010 events0 affected95 at risk EG0020 events0 affected48 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		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