Safety and Efficacy Study of Roxadustat (FG-4592) for the... | NCT02052310

ID	Type	Description	Link
2013-002753-30	EudraCT Number

Name	Class
Astellas Pharma Europe B.V.	INDUSTRY
AstraZeneca	INDUSTRY

Label	Type	Description	Intervention Names
Roxadustat	Experimental	Participants will receive roxadustat tablets, administered orally 3 times weekly (TIW). Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low weight [≤70 kilograms (kg)] and high weight [>70 to 160 kg] participants will receive 70 and 100 milligrams [mg] roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target hemoglobin (Hb) values (10-12 grams [g]/deciliter [dL]) will be based upon regular monitoring of Hb. The maximum roxadustat dose is 3.0 mg/kg per dose or 400 mg per administration (whichever is lower).	Drug: Roxadustat
Epoetin Alfa	Active Comparator	Participants on hemodialysis (HD) will receive epoetin alfa, administered intravenously (IV) TIW, with starting doses and dose adjustment rules as per United States Package Insert (USPI) or summary of product characteristics (SmPC). Participants on home HD or peritoneal dialysis (PD) will receive epoetin alfa, administered subcutaneously (SC) as per the country-specific product label (USPI or SmPC) or local standard of care (SOC).	Drug: Epoetin Alfa

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)	Hb values under the influence of rescue therapy were not censored for the primary analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (erythropoiesis-stimulating agent [ESA]) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group.	Baseline (Day 1, Week 0), Week 28 to 52
Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population)	Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion.	Baseline (Day 1, Week 0) up to Week 24

Secondary Outcomes

Measure	Description	Time Frame
US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population)	Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines.
Receiving HD or PD for ESRD for a minimum of 2 weeks and a maximum of 4 months, prior to randomization.
Hemodialysis access consisting of an arteriovenous (AV) fistula, AV graft, or tunnelled (permanent) catheter; or PD catheter in use.
Mean of the two most recent predialysis Hb values during the Screening Period, obtained at least 2 days apart, must be ≤ 10.0 g/dL, with a difference of ≤ 1.3 g/dL between the highest and the lowest values. The last Hb value must be drawn within 10 days prior to randomization.
Ferritin ≥ 100 nanograms (ng)/milliliter (mL) (≥ 220 picomoles (pmol)/L); participants with ferritin level < 100 ng/mL(<220 pmol/L) during screening, qualify after receiving iron supplement (per local standard of care), without the need to retest ferritin prior to randomization.
Transferrin saturation ≥ 20%; participants with TSAT level < 20% during screening, qualify after receiving iron supplement (per local standard of care), without the need to retest TSAT prior to randomization.
Serum folate level, performed within 8 weeks prior to randomization ≥ lower limit of normal (LLN); participants with serum folate level < LLN during screening, qualify after receiving folate supplement (per local standard of care), without the need to retest folate prior to randomization.
Serum vitamin B12 level, performed within 8 weeks prior to randomization ≥ LLN; participants with vitamin B12 level < LLN during screening, qualify after receiving B12 supplement (per local standard of care), without the need to retest B12 prior to randomization.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 * upper limit of normal (ULN), and total bilirubin ≤ 1.5 * ULN.
Body weight up to 160 kg (HD participants: dry weight).

Exclusion Criteria:

Total duration of prior effective ESA use must be ≤3 weeks within the preceding 12 weeks at the time informed consent is obtained.

Specific dosing guidance, depending on the type of ESAs, injected IV or SC within 12 weeks prior to start of screening are as follows:

i) Short-acting ESAs (EPO-alfa or equivalents) - IV: Up to 9 doses, last EPO dose must be ≥2 days prior to start of screening; SC: Up to 3 doses, last EPO dose must be ≥1 week (7 days) prior to start of screening ii) Darbepoetin - IV: Up to 3 doses, last darbepoetin dose must be ≥1 week (7 days) prior to start of screening; SC: Up to 2 doses, last darbepoetin dose must be ≥2 weeks (14 days) prior to start of screening iii) Continuous erythropoietin receptor activator (CERA) IV and SC: Up to 2 doses; last CERA dose must be ≥2 weeks (14 days) prior to start of screening

Intravenous iron: there is no restriction regarding IV iron use during screening, provided it is administered in accordance with local SOC.
Red blood cell transfusion within 4 weeks prior to randomization.
Active, clinically significant infection that could be manifested by white blood cell (WBC) count > ULN, and/or fever, in conjunction with clinical signs or symptoms of infection at the time of randomization.
History of chronic liver disease (for example, chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis, or fibrosis of the liver).
New York Heart Association Class III or IV congestive heart failure at screening.
Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event within a major vessel (excluding vascular dialysis access) (for example, deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
Uncontrolled hypertension, in the opinion of the Investigator, (for example, that requires a change in anti-hypertensive medication) within 2 weeks prior to randomization.
Renal imaging performed within 12 weeks prior to randomization indicative of a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category 2 or higher) of renal cell carcinoma.
History of malignancy, except for the following: cancers determined to be cured or in remission for ≥ 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab).
Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.
Known, untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration, or retinal vein occlusion (participants who are already blind for the above reasons qualify to participate).
Known history of myelodysplastic syndrome or multiple myeloma.
Known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than chronic kidney disease (CKD).
Known hemosiderosis, hemochromatosis, coagulation disorder, or a hypercoagulable condition.
Organ transplant: participants with any of the following:
1. Experienced rejection of a transplanted organ within 6 months of transplantation
2. Currently on high doses of immunosuppressive therapy (per discretion of the Investigator)
3. Scheduled for organ transplantation. Note: being on a waiting list for kidney transplant is not exclusionary
Anticipated elective surgery, except for vascular access surgery or dialysis catheter placement, that is expected to lead to significant blood loss, or anticipated elective coronary revascularization.
Active or chronic gastrointestinal bleeding.
Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
Use of iron-chelating agents within 4 weeks prior to randomization.
Known hypersensitivity reaction to any ESA.
Use of an investigational drug or treatment, participation in an investigational study, or presence of an expected carryover effect of an investigational treatment, within 4 weeks prior to randomization.
Anticipated use of dapsone or androgens at any dose amount or chronic use of acetaminophen or paracetamol > 2.0 g/day during the study.
History of alcohol or drug abuse within 6 months prior to randomization.
Females of childbearing potential, unless using contraception as detailed in the protocol; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use contraception.
Pregnant or breastfeeding females.
Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a participant in this study, may confound efficacy or safety assessment, or may interfere with study participation.

Name	Affiliation	Role
Charles Bradley, PhD	Kyntra Bio	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Chula Vista	California	91910	United States
Investigational Site

PubMed Identifier	Type	Citation	Retractions
38363466	Derived	Hamano T, Yamaguchi Y, Goto K, Martin S, Jiletcovici A, Dellanna F, Akizawa T, Barratt J. Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials. Adv Ther. 2024 Apr;41(4):1553-1575. doi: 10.1007/s12325-023-02728-2. Epub 2024 Feb 16.
36749544	Derived

ID	Title	Description
FG000	Roxadustat	Participants received roxadustat tablets, administered orally 3 times weekly (TIW). Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kilograms (kg)] and high weight [>70 to 160 kg] participants received 70 and 100 milligrams [mg] roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target hemoglobin (Hb) values (10-12 grams [g]/deciliter [dL]) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 20, 2017	Feb 10, 2021

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

US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)

Hb values under the influence of rescue therapy were not censored for the primary analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (erythropoiesis-stimulating agent [ESA]) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group.

The ITT population included all randomized participants.

Posted

Mean

Standard Deviation

g/dL

Baseline (Day 1, Week 0), Week 28 to 52

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.

Units	Counts
Participants	OG000522 OG001521

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0008.43± 1.044 OG0018.46± 0.964

Change at Week 28 to 52

Title	Measurements
	OG000

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	Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.	ANCOVA	ANCOVA with multiple imputation	0.0005		LS Mean Difference	0.18	Standard Error of the Mean	0.053	2-Sided	95	0.079	0.287					Non-Inferiority	Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.

Primary

Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population)

Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion.

The per protocol set (PPS) population included all participants in the full analysis set (FAS) population (all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment) who received at least 8 weeks of treatment and were without major protocol violations.

Posted

Number

percentage of participants

Baseline (Day 1, Week 0) up to Week 24

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.

Secondary

US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population)

The ITT population included all randomized participants.

Posted

Number

percentage of participants

Baseline (Day 1, Week 0) up to Week 24

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa

Secondary

Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population)

Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group.

The PPS population included all participants in the FAS population (all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment) who received at least 8 weeks of treatment and were without major protocol violations. Here, 'Number analyzed' signifies participants with non-missing data for this outcome measure at specified timepoint.

Posted

Mean

Standard Deviation

g/dL

Baseline (Day 1, Week 0), Week 28 to 52

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.

Secondary

Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 24

Baseline LDL Cholesterol was defined as the mean of values obtained within 6 weeks prior to the first dose of study treatment.

FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Number analyzed' signifies participants with non-missing data for this outcome measure at specified timepoints.

Posted

Mean

Standard Deviation

mg/dL

Baseline (Day 1, Week 0), Week 12 to 24

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.

Secondary

Mean Change From Baseline in Hb Levels Between Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN)

Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group.

FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

g/dL

Baseline (Day 1, Week 0), Week 18 to 24

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.

Secondary

Median Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52

Monthly iron use for each participant = Total IV iron in mg / [(last dose date - first dose date of study medication in the period)+1]/ 28.

Posted

Median

Full Range

mg/PEM

Weeks 28 to 52

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.

Secondary

Time to First RBC Transfusion

Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates.

FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment.

Posted

Median

95% Confidence Interval

weeks

Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 227.9 weeks for roxadustat and 226.9 weeks for epoetin alfa)

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.

Secondary

Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 8 to 12

Baseline MAP was defined as the last MAP value prior to the first dose of study treatment.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

Baseline (Day 1, Week 0), Weeks 8 to 12

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.

Secondary

Time to First Exacerbation of Hypertension During Weeks 28 to 52

An exacerbation of hypertension was defined as increase from baseline of ≥20 mmHg in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mm Hg in diastolic blood pressure (dBP) and dBP ≥100 mmHg. Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates.

FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment.

Posted

Median

95% Confidence Interval

weeks

Weeks 28 to 52

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.

Secondary

Percentage of Participants With Exacerbation of Hypertension During Weeks 28 to 52

Percentage of participants with exacerbation of hypertension, meeting at least one of the following criteria are reported: i) Increase in BP: An increase from baseline of ≥ 20 mmHg in sBP and sBP >170 mmHg, or an increase from baseline of ≥15 mmHg dBP and dBP >100 mmHg.

FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment.

Posted

Number

percentage of participants

Weeks 28 to 52

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.

Secondary

Time to Achieve the First Hb Response up to Week 24 Censoring for Rescue Therapy

Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Median time to event was calculated using Kaplan Meier Survival Estimates.

FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment.

Posted

Median

95% Confidence Interval

weeks

Baseline (Day 1, Week 0) up to Week 24

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa

Secondary

Percentage of Participants With Hb ≥10.0 g/dL Averaged Over Weeks 28 to 36 and 28 to 52, Regardless of Rescue Therapy

FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment.

Posted

Number

percentage of participants

Weeks 28 to 36 and 28 to 52

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.

Secondary

Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 36), Censoring for Rescue Therapy

Posted

Mean

Standard Deviation

g/dL

Baseline (Day 1, Week 0), Week 28 to 36

ID	Title	Description
OG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
OG001	Epoetin Alfa

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0006 affected522 at risk EG00111 affected517 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0005 affected522 at risk EG0017 affected517 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0005 affected522 at risk EG0012 affected517 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0015 affected517 at risk
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0015 affected517 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0015 affected517 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0005 affected522 at risk EG0010 affected517 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0015 affected517 at risk
Sudden Death	General disorders	MedDRA 20.0	Systematic Assessment		EG0007 affected522 at risk EG0014 affected517 at risk
Death	General disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0017 affected517 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG00030 affected522 at risk EG00126 affected517 at risk
Peritonitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG00012 affected522 at risk EG00112 affected517 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG00013 affected522 at risk EG0018 affected517 at risk
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0009 affected522 at risk EG0013 affected517 at risk
Gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0006 affected522 at risk EG0016 affected517 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0015 affected517 at risk
Device related sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0007 affected522 at risk EG0012 affected517 at risk
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0007 affected522 at risk EG0014 affected517 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0006 affected522 at risk EG0014 affected517 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG00039 affected522 at risk EG00121 affected517 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0005 affected522 at risk EG0012 affected517 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0009 affected522 at risk EG00112 affected517 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0016 affected517 at risk
Ischemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0005 affected522 at risk EG0012 affected517 at risk
Hemorrhagic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0016 affected517 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0005 affected522 at risk EG0015 affected517 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0016 affected517 at risk
Hypertensive crisis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0009 affected522 at risk EG00112 affected517 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0006 affected522 at risk EG0013 affected517 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0007 affected522 at risk EG0013 affected517 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0014 affected517 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0011 affected517 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0013 affected517 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Atrioventricular block	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0012 affected517 at risk
Bundle branch block left	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0011 affected517 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0013 affected517 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0011 affected517 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0014 affected517 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Pericarditis	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Fibrous dysplasia of bone	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Goitre	Endocrine disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Diabetic ophthalmoplegia	Eye disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Diabetic retinopathy	Eye disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Macular fibrosis	Eye disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Optic neuropathy	Eye disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Retinal artery occlusion	Eye disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0013 affected517 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0010 affected517 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0011 affected517 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Enteritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0013 affected517 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0011 affected517 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0011 affected517 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Pancreatic necrosis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Complication associated with device	General disorders	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0012 affected517 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Generalised oedema	General disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Hypothermia	General disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0010 affected517 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Sudden cardiac death	General disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Vascular stent stenosis	General disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0011 affected517 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Gallbladder necrosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Hepatic congestion	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Hepatic cyst ruptured	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Porcelain gallbladder	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Amoebiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Anal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Appendicitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0013 affected517 at risk
Bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Bacterial sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Bronchitis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Corona virus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Cystitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Dengue fever	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Diabetic foot infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Diabetic gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Endocarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Enterobacter infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Enterobacter sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Female genital tract tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Gallbladder empyema	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Groin abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Haematoma infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Hepatitis B	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Hepatitis C	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Infected fistula	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Infected dermal cyst	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Infected skin ulcer	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Infectious colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Localised infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Meningitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Necrotising soft tissue infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Nosocomial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0014 affected517 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Otitis externa	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0013 affected517 at risk
Periumbilical abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Post procedural sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Postoperative wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Pseudomonas infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0011 affected517 at risk
Rectal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Sinusitis aspergillus	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Small intestine gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Soft tissue infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0012 affected517 at risk
Staphylococcal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Tooth abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Toxic shock syndrome	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Wound sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Arteriovenous graft site stenosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0011 affected517 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0013 affected517 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Haemodialysis-induced symptom	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Vascular access malfunction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Vascular access site occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Vascular access site thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Anticoagulation drug level below therapeutic	Investigations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Blood potassium increased	Investigations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Coagulation time prolonged	Investigations	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Electrocardiogram abnormal	Investigations	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0012 affected517 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Nasopharyngeal neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Brain oedema	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Brain stem infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0013 affected517 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0013 affected517 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Dementia	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0011 affected517 at risk
Epilepsy	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Ischaemic neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Partial seizures	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Polyneuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Status migrainosus	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0012 affected517 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Vertigo CNS origin	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Device failure	Product Issues	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Device leakage	Product Issues	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Device occlusion	Product Issues	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0011 affected517 at risk
Thrombosis in device	Product Issues	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Major depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Suicide attempt	Psychiatric disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Azotaemia	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0012 affected517 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Renal papillary necrosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	This is a gender-specific AE that affects only male participants.	EG0001 affected309 at risk EG0010 affected307 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	This is a gender-specific AE that affects only male participants.	EG0000 affected309 at risk EG0011 affected307 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0014 affected517 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0010 affected517 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0012 affected517 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0003 affected522 at risk EG0014 affected517 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0014 affected517 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0011 affected517 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Treatment noncompliance	Social circumstances	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Aortic aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Aortic rupture	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Aortic stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0004 affected522 at risk EG0012 affected517 at risk
Dry gangrene	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0012 affected517 at risk
Extremity necrosis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Hypertensive emergency	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0013 affected517 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Malignant hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0011 affected517 at risk
Steal syndrome	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0011 affected517 at risk
Subgaleal haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Superior vena cava stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Thrombophlebitis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0010 affected517 at risk
Vascular occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Vascular rupture	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Vasculitis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Vasodilatation	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Venous occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Large intestinal polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Brain injury	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Ureteral necrosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0002 affected522 at risk EG0012 affected517 at risk
Refusal of treatment by patient	Social circumstances	MedDRA 20.0	Systematic Assessment		EG0001 affected522 at risk EG0010 affected517 at risk
Accelerated hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected522 at risk EG0011 affected517 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00072 affected522 at risk EG00138 affected517 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00045 affected522 at risk EG00130 affected517 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00035 affected522 at risk EG00123 affected517 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00032 affected522 at risk EG00117 affected517 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00026 affected522 at risk EG00128 affected517 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00027 affected522 at risk EG00142 affected517 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00025 affected522 at risk EG00131 affected517 at risk
Hyperphosphatemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00052 affected522 at risk EG00135 affected517 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00024 affected522 at risk EG00130 affected517 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00060 affected522 at risk EG00139 affected517 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00018 affected522 at risk EG00127 affected517 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00057 affected522 at risk EG00143 affected517 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00028 affected522 at risk EG00124 affected517 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00028 affected522 at risk EG00121 affected517 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG00030 affected522 at risk EG00122 affected517 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00096 affected522 at risk EG00187 affected517 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00049 affected522 at risk EG00133 affected517 at risk

ID	Term
D000740	Anemia
D051436	Renal Insufficiency, Chronic
D007676	Kidney Failure, Chronic

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

ID	Title	Description
BG000	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.
BG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.
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	Roxadustat	Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low weight [≤70 kg] and high weight [>70 to 160 kg] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks.	64	522	234	522	291	522
EG001	Epoetin Alfa	Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks.	54	517	218	517	262	517