A Study to Evaluate Efficacy of Dotinurad and Febuxostat... | NCT05007392

Label	Type	Description	Intervention Names
Drug: Dotinurad + Febuxostat Matched Placebo	Experimental	Participants will receive one dotinurad 1 mg tablet and one febuxostat 20 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then one dotinurad 2 mg tablet and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two dotinurad 2 mg tablets and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).	Drug: Dotinurad Other: Febuxostat Matched Placebo
Drug: Febuxostat + Dotinurad Matched Placebo	Active Comparator	Participants will receive one febuxostat 20 mg tablet and one dotinurad 1 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then two febuxostat 20 mg tablets and one dotinurad 2 mg matched placebo tablet, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two febuxostat 20 mg tablets and two dotinurad 2 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).	Drug: Febuxostat Other: Dotinurad Matched Placebo

Name	Type	Description	Arm Group Labels	Other Names
Dotinurad	Drug	Dotinurad oral tablets.	Drug: Dotinurad + Febuxostat Matched Placebo

Measure	Description	Time Frame
Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)	Percentage of participants with SUA level less than or equal to (<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.	At Week 24

Measure	Description	Time Frame
Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)	Percentage of participants with SUA level <=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method.	At Week 12
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Provincial Hospital		Hefei	Anhui	230001	China
Beijing Anzhen Hospital,Capital Medical University

ID	Title	Description
FG000	Febuxostat	Participants received febuxostat 20 milligrams (mg) tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
FG001	Dotinurad

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 7, 2021	Jul 10, 2025

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 Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)

Percentage of participants with SUA level less than or equal to (<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.

Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

percentage of participants

At Week 24

ID	Title	Description
OG000	Febuxostat	Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
OG001	Dotinurad	Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.

Units	Counts
Participants	OG000218 OG001220

Title

Denominators

Categories

Title	Measurements
	OG00038.1(31.6 to 44.5) OG00173.6(67.8 to 79.5)

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		Cochran-Mantel-Haenszel	P value based on a Cochran-Mantel-Haenszel test stratified by baseline SUA level and baseline body mass index (BMI) level.	<0.001		Difference of percentage	35.87			2-Sided	95	27.36	44.37			The difference of percentage and stratified 95 percent (%) confidence interval (CI) was based on Mantel-Haenszel method.		Superiority

Secondary

Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)

Percentage of participants with SUA level <=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method.

Posted

Number

95% Confidence Interval

percentage of participants

At Week 12

ID	Title	Description
OG000	Febuxostat	Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
OG001	Dotinurad	Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.

Secondary

Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24

Percentage of participants with SUA level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 was reported. Data was reported for observed participants at specified visits.

Posted

Number

percentage of participants

At Weeks 4, 8, 12, 16, 20 and 24

ID	Title	Description
OG000	Febuxostat	Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
OG001	Dotinurad	Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.

Secondary

Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24

Mean percent reduction from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.

Posted

Mean

Standard Deviation

Percent change in SUA level

Baseline, Weeks 4, 8, 12, 16, 20 and 24

ID	Title	Description
OG000	Febuxostat	Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
OG001	Dotinurad	Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.

Secondary

Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24

Mean change from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Weeks 4, 8, 12, 16, 20 and 24

ID	Title	Description
OG000	Febuxostat	Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
OG001	Dotinurad	Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.

Secondary

Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24

Mean SUA level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 was reported.

Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "number analyzed" signifies those participants who were evaluable at specified timepoints.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Weeks 4, 8, 12, 16, 20 and 24

ID	Title	Description
OG000	Febuxostat	Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
OG001	Dotinurad	Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0012 affected223 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Monocytopenia	Blood and lymphatic system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Monocytosis	Blood and lymphatic system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Sinus bradycardia	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0012 affected223 at risk
Bradycardia	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Bundle branch block right	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Sinus tachycardia	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0011 affected223 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0011 affected223 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Cardiac discomfort	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0010 affected223 at risk
Palpitations	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Right ventricular hypertrophy	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0010 affected223 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Dry eye	Eye disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Keratitis	Eye disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Xerophthalmia	Eye disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG00111 affected223 at risk
Toothache	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0014 affected223 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0013 affected223 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Anal eczema	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Duodenogastric reflux	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Flatulence	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Gingival pain	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Ileal ulcer	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Pyrexia	General disorders	MedDRA Version 26.0.	Systematic Assessment	EG00011 affected225 at risk EG0017 affected223 at risk
Fatigue	General disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Influenza like illness	General disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0011 affected223 at risk
Chest discomfort	General disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Chest pain	General disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Hyperthermia	General disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Version 26.0.	Systematic Assessment	EG00018 affected225 at risk EG00124 affected223 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0013 affected223 at risk
Liver injury	Hepatobiliary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0013 affected223 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Gallbladder enlargement	Hepatobiliary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0010 affected223 at risk
COVID-19	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG00057 affected225 at risk EG00157 affected223 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG00022 affected225 at risk EG00113 affected223 at risk
Coronavirus infection	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0015 affected223 at risk
Influenza	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0014 affected223 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0013 affected223 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0013 affected223 at risk
Bronchitis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0012 affected223 at risk
Pharyngitis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0012 affected223 at risk
Abscess limb	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Carbuncle	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Clonorchiasis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0011 affected223 at risk
Helicobacter infection	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Otitis media	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Paronychia	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Rhinitis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Soft tissue infection	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Tinea cruris	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Tinea pedis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Conjunctivitis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Gastroenteritis viral	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Hordeolum	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Onychomycosis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Periodontitis	Infections and infestations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0010 affected223 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0012 affected223 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0011 affected223 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Foreign body in eye	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Injury corneal	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0010 affected223 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG00028 affected225 at risk EG00118 affected223 at risk
SARS-CoV-2 test positive	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0008 affected225 at risk EG00117 affected223 at risk
Alpha 1 microglobulin increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG00019 affected225 at risk EG00112 affected223 at risk
Blood uric acid decreased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG00110 affected223 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG00012 affected225 at risk EG00110 affected223 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG00015 affected225 at risk EG0018 affected223 at risk
Blood creatinine increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0008 affected225 at risk EG0017 affected223 at risk
Low density lipoprotein increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0017 affected223 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG00012 affected225 at risk EG0016 affected223 at risk
Eosinophil count increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0016 affected223 at risk
High density lipoprotein decreased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0016 affected223 at risk
Beta 2 microglobulin urine increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0007 affected225 at risk EG0015 affected223 at risk
Amylase increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0014 affected223 at risk
Beta 2 microglobulin increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0014 affected223 at risk
Urine osmolarity decreased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0005 affected225 at risk EG0014 affected223 at risk
Blood cholesterol increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0013 affected223 at risk
Protein urine present	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0013 affected223 at risk
Urinary occult blood positive	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0013 affected223 at risk
White blood cell count decreased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0013 affected223 at risk
Beta-N-acetyl-D-glucosaminidase increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0007 affected225 at risk EG0012 affected223 at risk
Blood bilirubin increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Blood glucose increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0012 affected223 at risk
Blood pressure diastolic increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Neutrophil count decreased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Weight increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Alanine aminotransferase	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Albumin urine present	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Blood glucose	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0011 affected223 at risk
Blood pressure increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Blood triglycerides	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Blood triglycerides increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0011 affected223 at risk
Blood urea increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Bone density increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Coronavirus test positive	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Electrocardiogram ST segment elevation	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Globulins increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Hepatic enzyme increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Lymphocyte count increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Monocyte count decreased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Monocyte count increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Renal scan abnormal	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Urine albumin/creatinine ratio increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Urine leukocyte esterase positive	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Weight decreased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
White blood cells urine positive	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0010 affected223 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Blood glucose abnormal	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0010 affected223 at risk
Creatinine urine increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Electrocardiogram P wave abnormal	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Electrocardiogram Q waves	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Electrocardiogram ST segment abnormal	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0010 affected223 at risk
Electrocardiogram repolarisation abnormality	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Globulins decreased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Platelet count increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Transaminases increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Urinary occult blood	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0010 affected223 at risk
White blood cell count increased	Investigations	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG00013 affected225 at risk EG00116 affected223 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG00013 affected225 at risk EG0019 affected223 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0005 affected225 at risk EG0019 affected223 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0006 affected225 at risk EG0015 affected223 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0005 affected225 at risk EG0014 affected223 at risk
Hypouricaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0014 affected223 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0012 affected223 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0012 affected223 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0012 affected223 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Hyperhomocysteinaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0011 affected223 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0011 affected223 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG00078 affected225 at risk EG00197 affected223 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0015 affected223 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0013 affected223 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0012 affected223 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0012 affected223 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Bone hypertrophy	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Dizziness	Nervous system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0011 affected223 at risk
Headache	Nervous system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0011 affected223 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Dreamy state	Nervous system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Somnolence	Nervous system disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Insomnia	Psychiatric disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0012 affected223 at risk
Cardiovascular somatic symptom disorder	Psychiatric disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG00017 affected225 at risk EG00114 affected223 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0016 affected223 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0015 affected223 at risk
Renal cyst	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0005 affected225 at risk EG0014 affected223 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0013 affected223 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0005 affected225 at risk EG0012 affected223 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Albuminuria	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Renal injury	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Calculus bladder	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Calculus urinary	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Leukocyturia	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Renal milk of calcium cyst	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Urate nephropathy	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Prostatic calcification	Reproductive system and breast disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0012 affected223 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0013 affected223 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0012 affected223 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0003 affected225 at risk EG0011 affected223 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0002 affected225 at risk EG0011 affected223 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0004 affected225 at risk EG0010 affected223 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Urticaria papular	Skin and subcutaneous tissue disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Hypertension	Vascular disorders	MedDRA Version 26.0.	Systematic Assessment	EG0007 affected225 at risk EG0015 affected223 at risk
Phlebolith	Vascular disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0011 affected223 at risk

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

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Febuxostat	Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
BG001	Dotinurad	Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
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	Febuxostat	Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.	0	225	4	225	203	225
EG001	Dotinurad	Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.	0	223	3	223	201	223

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0000 affected225 at risk EG0011 affected223 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA Version 26.0.	Systematic Assessment	EG0001 affected225 at risk EG0010 affected223 at risk