Efficacy and Safety of Oral Febuxostat in Participants Wi... | NCT00430248

ID	Type	Description	Link
U1111-1114-0226	Registry Identifier	WHO

Label	Type	Description	Intervention Names
Febuxostat 40 mg QD	Experimental		Drug: Febuxostat
Febuxostat 80 mg QD	Experimental		Drug: Febuxostat
Allopurinol 200 mg or 300 mg QD	Active Comparator	(dependent on renal function)	Drug: Allopurinol

Name	Type	Description	Arm Group Labels	Other Names
Febuxostat	Drug	Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.	Febuxostat 40 mg QD

Measure	Description	Time Frame
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.	The percentage of subjects whose serum urate level was <6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.	Last Visit on treatment (up to 6 months)

Measure	Description	Time Frame
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl	The percentage of subjects with mild-to-moderate renal impairment whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.	Last Visit on treatment (up to 6 months)

Name	Affiliation	Role
Medical Director	Takeda	Study Chair

PubMed Identifier	Type	Citation	Retractions
20370912	Result	Becker MA, Schumacher HR, Espinoza LR, Wells AF, MacDonald P, Lloyd E, Lademacher C. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. doi: 10.1186/ar2978. Epub 2010 Apr 6.
21353107	Result	Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.

Label	URL
Uloric Package Insert	View source

ID	Title	Description
FG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
FG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.

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

Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.

The percentage of subjects whose serum urate level was <6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.

Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained.

Posted

Number

percentage of subjects

Last Visit on treatment (up to 6 months)

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants	OG000757 OG001756 OG002755

Title

Denominators

Categories

Title	Measurements
	OG00045.2 OG00167.1 OG00242.1

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 OG002	The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.					Difference in percentage	3.1				95	-1.9	8.1				Yes	Non-Inferiority or Equivalence	Noninferiority of febuxostat 40 mg to allopurinol was declared if the value of the lower bound of the 95% confidence interval for the difference was greater than -10%.

Secondary

Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl

The percentage of subjects with mild-to-moderate renal impairment whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.

Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level.

Posted

Number

percentage of subjects

Last Visit on treatment (up to 6 months)

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.

Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.

Posted

Number

percentage of subjects

Month 2

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.

Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.

Posted

Number

percentage of subjects

Month 4

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.

Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.

Posted

Number

percentage of participants

Month 6

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.

Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit

Posted

Number

percentage of subjects

Month 2

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.

Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.

Posted

Number

percentage of subjects

Month 4

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.

Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.

Posted

Number

percentage of subjects

Month 6

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.

The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.

Analysis was performed on the ITT subjects with a post-baseline serum urate value.

Posted

Number

percentage of subjects

Last Visit on treatment (up to 6 months)

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit

Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.

Posted

Number

percentage of subjects

Month 2

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit

Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.

Posted

Number

percentage of subjects

Month 4

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit

Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.

Posted

Number

percentage of subjects

Month 6

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts
Participants

Secondary

Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit

The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.

Analysis was performed on the ITT subjects with a post-baseline serum urate value.

Posted

Number

percentage of subjects

Last Visit on treatment (up to 6 months)

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts

Secondary

Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.

Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.

Posted

Mean

Standard Deviation

percent change from baseline

Baseline and Month 2

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts

Secondary

Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit

Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.

Posted

Mean

Standard Deviation

percent change from baseline

Baseline and Month 4

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts

Secondary

Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.

Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.

Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.

Posted

Mean

Standard Deviation

percent change from baseline

Baseline and Month 6

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts

Secondary

Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.

The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.

Analysis was performed on the ITT subjects with a post-baseline serum urate value.

Posted

Mean

Standard Deviation

percent change from baseline

Baseline and Last Visit on treatment (up to 6 months)

ID	Title	Description
OG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
OG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
OG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytoses not elsewhere classified (NEC)	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Thrombocytopenias	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Cardiac Conduction Disorders	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0012 affected756 at risk EG0020 affected756 at risk
Cardiac Hypertensive Complications	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Coronary Artery Disorders NEC	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected757 at risk EG0010 affected756 at risk EG0022 affected756 at risk
Heart Failures NEC	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Ischaemic Coronary Artery Disorders	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0012 affected756 at risk EG0021 affected756 at risk
Supraventricular Arrhythmias	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Inner Ear Signs and Symptoms	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Acute and Chronic Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Benign Neoplasms GastrointestinaI (Excluding Oral Cavity)	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0010 affected756 at risk EG0020 affected756 at risk
Dyspeptic Signs and Symptoms	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Gastrointestinal & Abdominal Pains (Excluding Oral and Throat)	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Gastrointestinal Ulcers and Perforation, Site Unspecified	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Intestinal Haemorrhages	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Intestinal Ulcers and Perforation NEC	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Nausea and Vomiting Symptoms	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Non-Site Specific Gastrointestinal Haemorrhages	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
General Signs and Symptoms NEC	General disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0010 affected756 at risk EG0020 affected756 at risk
Pain and Discomfort NEC	General disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0012 affected756 at risk EG0021 affected756 at risk
Cholecystitis and Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0023 affected756 at risk
Allergies to Food, Food Additives, Drugs and Other Chemicals	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Anaphylactic Responses	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0010 affected756 at risk EG0020 affected756 at risk
Abdominal and Gastrointestinal Infections	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Bacterial Infections NEC	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0011 affected756 at risk EG0022 affected756 at risk
Lower Respiratory Tract and Lung Infections	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0011 affected756 at risk EG0023 affected756 at risk
Sepsis, Bacteraemia, Viraemia, and Infections	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0021 affected756 at risk
Fractures and Dislocations NEC	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Muscle, Tendon and Ligament Injuries	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Non-Site Specific Injuries NEC	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0012 affected756 at risk EG0020 affected756 at risk
Non-Site Specific Procedural Complications	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Upper limb Fractures and Dislocations	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0021 affected756 at risk
Purine Metabolism Disorders NEC	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0021 affected756 at risk
Total Fluid Volume Decreased	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0010 affected756 at risk EG0020 affected756 at risk
Joint Related Disorders NEC	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Joint Related Signs and Symptoms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Osteoarthropathies	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Bladder Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Breast and Nipple Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0010 affected756 at risk EG0020 affected756 at risk
Colonic Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Nervous System Neoplasms Unpecified Malignancy NEC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Nonsmall Cell Neoplasm Malignant/Respiratory Type Specified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk
Prostatic Neoplasms Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Prostatic Neoplasms Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0023 affected756 at risk
Central Nervous System Hemorrhages & Cerebrovascular Accidents	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0021 affected756 at risk
Disturbances in Consciousness NEC	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0010 affected756 at risk EG0023 affected756 at risk
Increased Intracranial Pressure Disorders	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Neurological Signs and Symptoms NEC	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0010 affected756 at risk EG0020 affected756 at risk
Transient Cerebrovascular Events	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0011 affected756 at risk EG0021 affected756 at risk
Renal Failure and Impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Renal Vascular and Ischaemic Conditions	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Prostatic Signs, Symptoms and Disorders NEC	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Bronchospasms and Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0021 affected756 at risk
Pulmonary Thrombotic and Embolic Conditions	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected757 at risk EG0011 affected756 at risk EG0020 affected756 at risk
Aortic Aneurysms and Dissections	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected757 at risk EG0010 affected756 at risk EG0021 affected756 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D006073	Gout
D033461	Hyperuricemia

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070657	Crystal Arthropathies
D012216	Rheumatic Diseases
D011686	Purine-Pyrimidine Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.
BG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.
BG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)
EG000	Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily for up to 6 months.	19	193
EG001	Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily for up to 6 months.	28	167
EG002	Allopurinol 200 mg or 300 mg QD	Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.	31	166

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper Respiratory Tract Infections	Infections and infestations	MedDRA	Systematic Assessment	EG00071 affected757 at risk EG00153 affected756 at risk EG00257 affected756 at risk
Liver Function Analyses	Investigations	MedDRA	Systematic Assessment	EG00063 affected757 at risk EG00152 affected756 at risk EG00250 affected756 at risk
Diarrhoea (Excluding Infective)	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00045 affected757 at risk EG00147 affected756 at risk EG00257 affected756 at risk
Musculoskeletal and Connective Tissues Signs and Symptoms NEC	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00043 affected757 at risk EG00138 affected756 at risk EG00232 affected756 at risk