Comparison of Two Medications Aimed at Slowing Aortic Roo... | NCT00429364

ID	Type	Description	Link
U01HL068270	U.S. NIH Grant/Contract		View source

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
FDA Office of Orphan Products Development	FED
National Marfan Foundation	UNKNOWN

Label	Type	Description	Intervention Names
Atenolol	Active Comparator	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.	Drug: Atenolol
Losartan	Active Comparator	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).	Drug: Losartan Potassium

Name	Type	Description	Arm Group Labels	Other Names
Losartan Potassium	Drug	Losartan .3 - 1.4 mg/kg	Losartan	Cozaar

Measure	Description	Time Frame
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score	The rate of aortic root enlargement, expressed as the annual change in the maximum aortic-root-diameter z score indexed to body-surface area over a 3-year period following randomization	Up to 3 years following randomization.

Measure	Description	Time Frame
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension	The rate of change in the absolute dimension of the aortic root over a 3-year period following randomization	Up to 3 years following randomization.
Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.

Name	Affiliation	Role
Ron Lacro, MD	Boston Children's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	United States
Lucile Packard Children's Hospital

PubMed Identifier	Type	Citation	Retractions
29948025	Derived	Hoskoppal A, Menon S, Trachtenberg F, Burns KM, De Backer J, Gelb BD, Gleason M, James J, Lai WW, Liou A, Mahony L, Olson AK, Pyeritz RE, Sharkey AM, Stylianou M, Wechsler SB, Young L, Levine JC, Tierney ESS, Lacro RV, Bradley TJ; Pediatric Heart Network Investigators. Predictors of Rapid Aortic Root Dilation and Referral for Aortic Surgery in Marfan Syndrome. Pediatr Cardiol. 2018 Oct;39(7):1453-1461. doi: 10.1007/s00246-018-1916-6. Epub 2018 Jun 11.
25405392

Label	URL
Click here for the Pediatric Heart Network Web site	View source

ID	Title	Description
FG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
FG001	Losartan

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

Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score

The rate of aortic root enlargement, expressed as the annual change in the maximum aortic-root-diameter z score indexed to body-surface area over a 3-year period following randomization

Posted

Least Squares Mean

Standard Error

z-score/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000303 OG001305

Title

Denominators

Categories

Title	Measurements
	OG000-0.139± 0.013 OG001-0.107± 0.013

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 Models Analysis		0.08	P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.					2-Sided								Superiority or Other (legacy)

Secondary

Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension

The rate of change in the absolute dimension of the aortic root over a 3-year period following randomization

Posted

Least Squares Mean

Standard Error

cm/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.

All randomized participants whose ascending-aorta-diameter z scores were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

z-score/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in the Absolute Diameter of the Ascending Aorta

All randomized participants whose absolute dimensions of the ascending aorta were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

cm/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area

All randomized participants whose aortic-annulus-diameter z scores were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

z-score/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in the Absolute Diameter of the Aortic Annulus

All randomized participants whose absolute dimensions of the aortic annulus were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

cm/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area

All randomized participants whose total aortic proximal regurgitant jet area indexes were measured at baseline or at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

(mm^2/m^2)/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Weight

Posted

Least Squares Mean

Standard Error

kg/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Weight-for-age Z-score

All randomized participants who were between 0-20 years of age and whose weight-for-age z-scores were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

z-score/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Weight-for-height Z-score

All randomized participants who were <120 cm in heights and whose weight-for-height z-scores were measured at baseline or at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

z-score/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Height

All randomized participants whose heights were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

cm/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Height-for-age Z-score

All randomized participants who were between 0-20 years of age and whose heights were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

z-score/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Body Mass Index

All randomized participants whose body mass indexes were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

kg/m^2 per year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Body Mass Index for Age Z-score

All randomized participants who were between 0-20 years of age and whose body mass index for age z-scores were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

z-score/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Arm Span to Height Ratio

All randomized participants whose arm span to height ratios were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

1/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Annual Rate of Change in Upper to Lower Segment Ratio

All randomized participants whose upper to lower segment ratios were measured at baseline and at any of the follow-up visits.

Posted

Least Squares Mean

Standard Error

1/year

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Aortic Dissection.

All randomized participants who received the treatment

Posted

Number

participants

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Event Rate of Aortic Dissection.

Percentage of participants who had aortic dissection over a 3-year period following randomization.

All randomized participants who received the treatment

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Aortic-root Surgery.

All randomized participants who received the treatment

Posted

Number

participants

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Event Rate of Aortic-Root Surgery

Percentage of participants who had aortic-root surgery over a 3-year period following randomization.

All randomized participants who received the treatment

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Number of Death.

All randomized participants who received the treatment

Posted

Number

participants

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Event Rate of Death

Percentage of participants who died over a 3-year period following randomization.

All randomized participants who received the treatment

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.

All randomized participants who received the treatment

Posted

Number

participants

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.

Percentage of participants who had aortic dissection, aortic-root surgery or death over a 3-year period following randomization

All randomized participants who received the treatment

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Adverse Drug Reactions Reported at the Baseline Visit

All randomized participants.

Posted

Number

participants

At baseline

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Secondary

Adverse Drug Reactions Reported During Routine Follow-up Surveillance

All subjects who had any of the follow-up visits after 6 months post-randomization.

Posted

Number

participants

From 6 months to 3 years following randomization.

ID	Title	Description
OG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
OG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood/bone marrow(sickle cell crisis)	Blood and lymphatic system disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Atrial fibrillation	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0014 events2 affected305 at risk
Left ventricular failure	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Pericarditis NOS	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Supraventricular tachycardia	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Valvular heart disease NOS	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0013 events3 affected305 at risk
Ventricular tachycardia	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Retinal detachment	Eye disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Abdominal pain NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Diarrhoea NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Pancreatitis NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Chest pain	General disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0012 events2 affected305 at risk
Pyrexia	General disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Autoimmune disorder NOS	Immune system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events1 affected303 at risk EG0011 events1 affected305 at risk
Hypersensitivity NOS	Immune system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Serum sickness	Immune system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Cellulitis	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Pneumonia	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0005 events4 affected303 at risk EG0011 events1 affected305 at risk
Respiratory tract infection NOS	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Soft tissue infection NOS	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Urinary tract infection NOS	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Viral infection	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Wound - snake bite	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Wound infection	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0012 events1 affected305 at risk
Haematoma	Injury, poisoning and procedural complications	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Vascular: vessel injury-artery, other NOS	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Weight decreased	Investigations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0010 events0 affected305 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Cerebral abscess	Nervous system disorders		Non-systematic Assessment	EG0002 events1 affected303 at risk EG0010 events0 affected305 at risk
Convulsions NOS	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Dizziness	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Headache	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0012 events2 affected305 at risk
Agitation	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0013 events2 affected305 at risk
Anxiety	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events2 affected303 at risk EG0010 events0 affected305 at risk
Depression	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0011 events1 affected305 at risk
Psychosis aggravated	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Urethral obstruction	Renal and urinary disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Uterine haemorrhage	Reproductive system and breast disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Pneumonitis NOS	Respiratory, thoracic and mediastinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Pneumothorax NOS	Respiratory, thoracic and mediastinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0017 events5 affected305 at risk
Pulmonary/upper respiratory-other	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Culture wound negative	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Aortic root enlargement	Surgical and medical procedures		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Cardiac General-other: mitral valve replacement	Surgical and medical procedures		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Thrombosis	Vascular disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Haemoglobin	Blood and lymphatic system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0012 events2 affected305 at risk
Lymph node pain	Blood and lymphatic system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Cardiac General - Other - Murmur	Cardiac disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Cardiac General - other - nonresponsive and pale	Cardiac disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Palpitations	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0009 events9 affected303 at risk EG00110 events10 affected305 at risk
Sinus tachycardia	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Supraventricular tachycardia	Cardiac disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Auditory/ear-other	Ear and labyrinth disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Hypersensitivity to sound	Ear and labyrinth disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Hot flushes NOS	Endocrine disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Conjunctivitis	Eye disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0011 events1 affected305 at risk
Eyelid function disorder NOS	Eye disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Lacrimation increased	Eye disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Ocular-other (L eye burning/redness 4 mos. s/p lensectomy with lens insertion)	Eye disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Ocular-other (right eye hemorrhage)	Eye disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Ocular/Visual - Squinting of OS to see things more clearly.	Eye disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Ocular/visual-other (redness and itching of eyes)	Eye disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Photopsia	Eye disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Vision blurred	Eye disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Abdominal pain NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0007 events7 affected303 at risk EG0017 events7 affected305 at risk
Constipation	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0004 events4 affected303 at risk EG0012 events2 affected305 at risk
Diarrhoea NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0006 events4 affected303 at risk EG0012 events2 affected305 at risk
Dysgeusia	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0012 events2 affected305 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Dysphagia	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Gastrointestinal - HERNIA	Gastrointestinal disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Haemorrhoids	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Intestinal Hernia	Gastrointestinal disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Nausea	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events2 affected303 at risk EG0013 events2 affected305 at risk
Oesophageal pain	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Oral pain	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Oseophagitis NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Peridontal disorder NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Stomach discomfort	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0005 events5 affected303 at risk EG0013 events3 affected305 at risk
Tooth disorder NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Vomiting NOS	Gastrointestinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events2 affected303 at risk EG0017 events5 affected305 at risk
Bilateral pedal edema	General disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Chest pain	General disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG00018 events16 affected303 at risk EG00118 events17 affected305 at risk
Constitutional symptoms -other(flu)	General disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Constitutional symptoms-other (unusual dreams)	General disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Constitutional-other (general body cold sensation)	General disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Edema:head and neck	General disorders		Non-systematic Assessment	EG0002 events2 affected303 at risk EG0012 events2 affected305 at risk
Edema:limb	General disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0012 events1 affected305 at risk
Falling asleep	General disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Fatigue	General disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG00019 events18 affected303 at risk EG00112 events11 affected305 at risk
Hypothermia	General disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Influenza-like illness	General disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Nightmare	General disorders		Non-systematic Assessment	EG0008 events7 affected303 at risk EG00113 events13 affected305 at risk
Pain-other (right hip pain)	General disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Pain-other:chest pain/costochondritis (diagnosed in ER as costochondritis)	General disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Pyrexia	General disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0006 events4 affected303 at risk EG0012 events2 affected305 at risk
Allergy/Immunology - Other (rash)	Immune system disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Hypersensitivity NOS	Immune system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0013 events3 affected305 at risk
Abcessed tooth	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Bronchitis NOS	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Gum infection	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Infection - Eye NOS	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Infection - Other - Parvovirus	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Infection Pharnyx	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Infection with unknown ANC-eye, NOS	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Infection with unknown ANC-middle ear	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Infection with unknown ANC-pharynx	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0012 events2 affected305 at risk
Infection with unknown ANC-sinus	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Infection with unknown ANC-upper ariway NOS	Infections and infestations		Non-systematic Assessment	EG0002 events2 affected303 at risk EG0010 events0 affected305 at risk
Infection-bladder(urinary)	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Infection-other (sinus, bronchitis, pharyngeal)	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Infection-other (skin on foot)	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Infection-other-Lyme disease	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Infection: Dental - Tooth	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Middle ear infection	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0012 events2 affected305 at risk
Mononucleosis	Infections and infestations		Non-systematic Assessment	EG0003 events3 affected303 at risk EG0011 events1 affected305 at risk
Pneumonia	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0014 events4 affected305 at risk
Shingles	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Sinus infection	Infections and infestations		Non-systematic Assessment	EG0002 events2 affected303 at risk EG0010 events0 affected305 at risk
Sinusitis NOS	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events2 affected303 at risk EG0011 events1 affected305 at risk
Urinary tract infection NOS	Infections and infestations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Vaginitis	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Viral infection coxsackievirus	Infections and infestations		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Haematoma	Injury, poisoning and procedural complications	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Neutrophil count	Investigations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Weight decreased	Investigations	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0013 events3 affected305 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0013 events3 affected305 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0008 events8 affected303 at risk EG0018 events8 affected305 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0006 events6 affected303 at risk EG0015 events5 affected305 at risk
Joint disorder NOS	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Msk/soft tissue, other (Nodule on back)	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Muscle weakness, generalized or specific area	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Musculoskeletal (other) (loose joints-causing pain)	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Musculoskeletal/soft tissue - other (patellar dislocation)	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Musculoskeletal/soft tissue-other (Bursa on left shoulder blade due to back brace)	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Musculoskeletal/soft tissue-other (nodule on back)	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Musculoskeletal/soft tissue-other( left arm pain)	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG00112 events12 affected305 at risk
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0012 events2 affected305 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0005 events5 affected303 at risk EG0014 events4 affected305 at risk
Cognitive disorder	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events2 affected303 at risk EG0012 events2 affected305 at risk
Convulsions NOS	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0010 events0 affected305 at risk
Dizziness	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG00029 events29 affected303 at risk EG00118 events17 affected305 at risk
Dizziness upon standing	Nervous system disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Extrapyramidal disorder	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events2 affected303 at risk EG0010 events0 affected305 at risk
Headache	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG00036 events31 affected303 at risk EG00119 events18 affected305 at risk
Memory impairment	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Mental status changes	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Neuralgia NOS	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Neurology - other	Nervous system disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0012 events2 affected305 at risk
Neurology-other (panic attacks)	Nervous system disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0012 events1 affected305 at risk
Panick attack	Nervous system disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Syncope	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG00014 events13 affected303 at risk EG0019 events9 affected305 at risk
Syncope vasovagal	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events2 affected303 at risk EG0013 events2 affected305 at risk
Tremor	Nervous system disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Sexual/reproductive function-other (4.5 cm cyst on right ovary)	Pregnancy, puerperium and perinatal conditions		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Sexual/reproductive function-other (abnormal pap smear)	Pregnancy, puerperium and perinatal conditions		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Agitation	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG00012 events11 affected303 at risk EG0013 events3 affected305 at risk
Anxiety	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0005 events5 affected303 at risk EG0012 events2 affected305 at risk
Confusional state	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Depression	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG00011 events9 affected303 at risk EG0013 events2 affected305 at risk
Insomnia	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG00010 events10 affected303 at risk EG00112 events12 affected305 at risk
Mood alteration	Psychiatric disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Neurology-other (expression of anger and sadness)	Psychiatric disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Neurology-other (irritability)	Psychiatric disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Personality change	Psychiatric disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0006 events6 affected303 at risk EG0013 events3 affected305 at risk
Chromaturia	Renal and urinary disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Pollakiuria	Renal and urinary disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Renal/genitourinary-increased urinary frequency, daytime only, associated w/ po water intake	Renal and urinary disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Urinary incontinence	Renal and urinary disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events1 affected303 at risk EG0010 events0 affected305 at risk
Urogenital haemorrhage	Renal and urinary disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Gynaecomastia	Reproductive system and breast disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0014 events4 affected305 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0014 events4 affected305 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0006 events6 affected303 at risk EG0015 events5 affected305 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0009 events9 affected303 at risk EG0017 events7 affected305 at risk
Hemorrhage/Bleeding - other	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0002 events2 affected303 at risk EG0013 events3 affected305 at risk
Nasal conjestion/inf with unk ANC upper airway NOS	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Obstructive sleep apnea	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Pulmonary/upper respiratory-other	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Upper Respiratory - Other	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Acne NOS	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0002 events2 affected303 at risk EG0012 events2 affected305 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0014 events4 affected305 at risk
Burn on skin	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Derm/skin-other (Poison Ivy)	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Derm/skin-other (mild chin rash)	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Derm/skin-other (possible aczema)	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Derm/skin-other (worsening of underlying hand skin disorder)	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Dermatitis exfoliative NOS	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Dermatology - other - Erythema Nodosum	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Dermatology/skin-other (Poison Ivy)	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Dermatology/skin-other (cervical dysplasia)	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Dermatology/skin-other (papules on legs)	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Dermatology/skin-other (rash: nonspecific maculopapular rash)	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0012 events2 affected305 at risk
Eczema	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0011 events1 affected305 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0004 events3 affected303 at risk EG0010 events0 affected305 at risk
Rash	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Rash on torso and neck	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Skin irritation	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0001 events1 affected303 at risk EG0013 events2 affected305 at risk
Sweating increased	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Urticaria NOS	Skin and subcutaneous tissue disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0003 events3 affected303 at risk EG0014 events4 affected305 at risk
Cardiac general-chest tightness	Surgical and medical procedures		Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk
Flushing	Vascular disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Hypertension NOS	Vascular disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0001 events1 affected303 at risk EG0010 events0 affected305 at risk
Hypotension NOS	Vascular disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0013 events3 affected305 at risk
Raynaud's Phenomena	Vascular disorders		Non-systematic Assessment	EG0002 events2 affected303 at risk EG0011 events1 affected305 at risk
Thrombosis	Vascular disorders	CTCAE 3.0 MedDRA 6.0	Non-systematic Assessment	EG0000 events0 affected303 at risk EG0011 events1 affected305 at risk

ID	Term
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000015	Abnormalities, Multiple
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D030342	Genetic Diseases, Inborn
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D000094629	Dissection, Thoracic Aorta
D000784	Aortic Dissection
D000094665	Dissection, Blood Vessel
D000783	Aneurysm
D014652	Vascular Diseases
D000094683	Acute Aortic Syndrome
D001018	Aortic Diseases

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D020005	Propanols
D000588	Amines

ID	Title	Description
BG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
BG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Atenolol	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.			27	303	135	303
EG001	Losartan	Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).			33	305	121	305