Phase II Dose Finding Study of RDEA3170 Versus Placebo in... | NCT02078219

NCT02078219

ID	Type	Description	Link
RDEA3170-203	Other Identifier	Ardea Biosciences, Inc.

Status Module

Sponsor/Collaborators Module

Name	Class
Ardea Biosciences, Inc.	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RDEA3170 1	Experimental	RDEA3170 5mg followed by RDEA3170 7.5mg	Drug: RDEA3170
RDEA3170 2	Experimental	RDEA3170 10mg followed by RDEA3170 12.5mg	Drug: RDEA3170
RDEA3170 3	Experimental	RDEA3170 12.5mg followed by RDEA3170 15mg	Drug: RDEA3170
RDEA3170 4	Placebo Comparator	RDEA3170 Placebo	Drug: Placebo
Allopurinol	Other	Allopurinol 200mg	Drug: Allopurinol

Name	Type	Description	Arm Group Labels	Other Names
RDEA3170	Drug	Oral Treatment	RDEA3170 1 RDEA3170 2 RDEA3170 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Changes of Serum Uric Acid Levels From Baseline Levels	The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.	Baseline and Week 16

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL	To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit	Weeks 1,2,4,6,8,10,12,16,18,20,24
Percent Change in sUA

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Chofu-shi		182-0006	Japan
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Allopurinol 200 mg Treatment Group	100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks
FG001	RDEA3170 Placebo Treatment Group	RDEA3170 matching placebo qd for 24 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

No subject was excluded from the safety and efficacy analysis sets. Some data points of 3 subjects who have incompliance were excluded from the PK analyses due to incorrect dose of RDEA3170

Arm/Group Information

ID	Title	Description
BG000	Allopurinol 200 mg Treatment Group	100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks
BG001	RDEA3170 Placebo Treatment Group	RDEA3170 matching placebo qd for 24 weeks
BG002	RDEA3170 Treatment Group 1	RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
BG003	RDEA3170 Treatment Group 2	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
BG004	RDEA3170 Treatment Group 3	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG00041 BG00140 BG00241 BG00341 BG00441 BG005204

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-30.93± 17.80 OG001-49.91± 18.38 OG002-54.32± 13.40 OG003

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 OG003		ANCOVA, LOCF		<0.0001		Mean Difference (Final Values)	-29.28			2-Sided	95	-36.99	-21.57					Superiority or Other (legacy)
OG001 OG003		ANCOVA, LOCF		<0.0001

Secondary

Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL

To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit

Efficacy analysis set

Posted

Number

% subjects

Weeks 1,2,4,6,8,10,12,16,18,20,24

ID	Title	Description
OG000	RDEA3170 Treatment Group 1	RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
OG001	RDEA3170 Treatment Group 2	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
OG002	RDEA3170 Treatment Group 3	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
OG003	RDEA3170 Placebo Treatment Group	RDEA3170 matching placebo qd for 24 weeks

Secondary

Percent Change in sUA

To compare percent change in sUA at each study visit.

Efficacy analysis set

Posted

Mean

Standard Deviation

% Change

Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

ID	Title	Description
OG000	RDEA3170 Treatment Group 1	RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
OG001	RDEA3170 Treatment Group 2	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
OG002	RDEA3170 Treatment Group 3	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
OG003	RDEA3170 Placebo Treatment Group	RDEA3170 matching placebo qd for 24 weeks

Secondary

Absolute Change of Serum Uric Acid Levels From Baseline Levels

To compare the absolute change of serum uric acid levels from baseline levels

Efficacy analysis set

Posted

Mean

Standard Deviation

mg/dL

Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

ID	Title	Description
OG000	RDEA3170 Treatment Group 1	RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
OG001	RDEA3170 Treatment Group 2	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
OG002	RDEA3170 Treatment Group 3	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
OG003	RDEA3170 Placebo Treatment Group	RDEA3170 matching placebo qd for 24 weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Allopurinol 200 mg Treatment Group	allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks.	1	41	22	41
EG001	RDEA3170 Placebo Treatment Group	RDEA3170 matching placebo qd for 24 weeks	1	40	23	40
EG002	RDEA3170 Treatment Group 1	RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks	1	41	26	41
EG003	RDEA3170 Treatment Group 2	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks	1	41	26	41
EG004	RDEA3170 Treatment Group 3	RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks	0	41	21	41

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Silent myocardial infarction	Cardiac disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG0030 affected41 at risk EG0040 affected41 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
VIIth nerve paralysis	Nervous system disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0007 affected41 at risk EG0017 affected40 at risk EG0029 affected41 at risk EG0038 affected41 at risk EG0046 affected41 at risk
Pharyngitis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk EG0022 affected41 at risk EG003
Bronchitis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk EG0021 affected41 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk EG0021 affected41 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk EG0021 affected41 at risk EG003
Chronic pigmented purpura	Skin and subcutaneous tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk EG0021 affected41 at risk EG003
Hypertension	Vascular disorders	MedDRA version 17.1	Systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk EG0021 affected41 at risk EG003
Headache	Nervous system disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Blood creatinine increased	Investigations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0022 affected41 at risk EG003
Insomnia	Psychiatric disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk EG0021 affected41 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Contact stomatitis	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Conjunctivitis viral	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Gingivitis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Influenza	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Nasal vestibulitis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Sinusitis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Tonsillitis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Urethritis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Periodontitis	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Oral herpes	Infections and infestations	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Somnolence	Nervous system disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
VIIth nerve paralysis	Nervous system disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Weight increased	Investigations	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Muscle contusion	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Venomous sting	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Foreign body	Injury, poisoning and procedural complications	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Depression	Psychiatric disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0013 affected40 at risk EG0020 affected41 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Tachycardia	Cardiac disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Silent myocardial infarction	Cardiac disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Conjunctivitis	Eye disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Dry eye	Eye disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Glaucoma	Eye disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Fatigue	General disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Local swelling	General disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Oedema peripheral	General disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Pyrexia	General disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk EG0020 affected41 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0021 affected41 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk EG0020 affected41 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA version 17.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003

ID	Term
D006073	Gout
D033461	Hyperuricemia

Ancestor Terms

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
C000628929	verinurad
D000493	Allopurinol

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ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds