Study of Roxadustat Conversion in Participants Receiving... | NCT04484857

NCT04484857

Status Module

Sponsor/Collaborators Module

Name	Class
AstraZeneca	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
Roxadustat	Experimental	Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant require roxadustat <60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency will be reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from an ESA, the initial roxadustat dose will be based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta [Mircera®]). For participants with <6 weeks of prior ESA use, the initial roxadustat dose will be based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations will be made every 4 weeks and doses will be titrated based on Hb level and rate of Hb change. The prescribed dose will not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever is lower.	Drug: Roxadustat

Name	Type	Description	Arm Group Labels	Other Names
Roxadustat	Drug	Roxadustat will be administered per dose and schedule specified in the arm description.	Roxadustat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Mean Hb Value ≥10 g/dL	Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.	Week 16 through Week 24
Mean Hb Change From Baseline to Average Hb From Weeks 16-24	Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model.	Baseline, Weeks 16-24

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Receiving chronic dialysis for end stage renal disease (ESRD)
Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunnelled catheter
Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams (g)/deciliter (dL); Participants initiating anemia treatment: < 10.0 g/dL
Ferritin ≥ 50 nanograms (ng)/mililiter (mL), Transferrin saturation (TSAT) ≥ 10% at screening
Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤ 1.5 x ULN at screening and prior to initiating roxadustat treatment.
Body weight between 45.0 to 160.0 kg

Key Exclusion Criteria:

Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
Known history of myelodysplastic syndrome or multiple myeloma
Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
Active or chronic gastrointestinal bleeding
Treated with iron-chelating agents within 4 weeks prior to enrollment
History of New York Heart Association (NYHA) Class III or IV congestive heart failure
History of myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment
Uncontrolled hypertension, in the opinion of the Investigator
Participant has a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma (Principal Investigator's discretion)
History of malignancy, except for cancers determined to be cured or in remission for ≥ 2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps

Contacts/Locations Module

Name	Affiliation	Role
Mark Eisner	Kyntra Bio	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Alaska		Anchorage	Alaska	99515	United States
Investigator Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Roxadustat	Participants received roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant required roxadustat <60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency was reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from an erythropoiesis stimulating agent (ESA), the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta [Mircera®]). For participants with <6 weeks of prior ESA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever was lower.

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

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 20, 2020	Jul 1, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

Arm/Group Information

ID	Title	Description
BG000	Roxadustat	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat <60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with <6 weeks of prior ESA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.

Units	Counts
Participants	BG000283

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
	BG00059.0± 13.12

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000116
Male	BG000167

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00091
Not Hispanic or Latino	BG000191

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
Black or African American	BG000113
American Indian or Alaska Native	BG000

Baseline Hb

Mean

Standard Deviation

grams (g)/deciliter (dL)

Title

Denominators

Categories

Title	Measurements
	BG00010.554± 0.7228

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 Mean Hb Value ≥10 g/dL

Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.

The full analysis set included all enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point.

Posted

Number

95% Confidence Interval

percentage of participants

Week 16 through Week 24

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat <60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with <6 weeks of prior ESA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.

Units	Counts
Participants	OG000282

Title

Denominators

Categories

Title	Measurements
	OG00083.7(78.9 to 88.6)

Primary

Mean Hb Change From Baseline to Average Hb From Weeks 16-24

Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model.

The full analysis set included all enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point.

Posted

Mean

Standard Deviation

g/dL

Baseline, Weeks 16-24

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat <60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with <6 weeks of prior ESA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Roxadustat	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat <60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with <6 weeks of prior ESA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.	11	283	82	283	19	283

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0007 affected283 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected283 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected283 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Angina unstable	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Orbital haematoma	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Non-cardiac chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
General physical health deterioration	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Organ failure	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Treatment noncompliance	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Haemorrhagic hepatic cyst	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00010 affected283 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0007 affected283 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0005 affected283 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0005 affected283 at risk
Sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Bone abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Diabetic foot infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Enterobacter sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Enterococcal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Escherichia infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Gangrene	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Helicobacter infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Herpes zoster	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Septic shock	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Skin infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0003 affected283 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Arteriovenous graft site pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Vascular access site pain	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0006 affected283 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected283 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Pain in extremityvvv	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Dysarthria	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Encephalopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Syncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Confusional state	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Mental status changes	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Azotaemia	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Hydroureter	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Scrotal swelling	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0009 affected283 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected283 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected283 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected283 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected283 at risk
Hypertensive emergency	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected283 at risk
Hypertensive urgency	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected283 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected283 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Embolism	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected283 at risk

ID	Term
C584543	roxadustat