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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000951-42 | EudraCT Number |
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| Name | Class |
|---|---|
| Kyntra Bio | INDUSTRY |
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The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.
This was a phase 3, multicenter, randomized, open-label, active-controlled study. The study was planned to provide key efficacy and safety data for the approval of roxadustat in the treatment of anemia associated with CKD. Participants assigned to roxadustat treatment were administered roxadustat orally as a combination of tablets of different strengths. Participants assigned to darbepoetin alfa treatment were administered darbepoetin alfa subcutaneously or intravenously.
The study consisted of 3 study periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxadustat | Experimental | Participants received roxadustat orally according to the tiered weight-based approach, with starting dose of 70 mg (milligram) given thrice weekly (TIW) to participants weighing up to 70 kg (kilogram) and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL (gram per deciliter) and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat up to a maximum of 104 weeks. |
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| Darbepoetin alfa | Active Comparator | Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 μg/kg (microgram per kilogram), as a single subcutaneous or intravenous (IV) injection once weekly or 0.75 μg/kg, as a single subcutaneous injection once every 2 weeks) as per European Summary of Product Characteristics (EU SmPC) along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat | Drug | Oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy | Hb response was measured as Yes or No. Response Yes (responders) was defined as: Hb ≥11.0 g/dL and Hb change from baseline by ≥ 1.0 g/dL, for participants with baseline Hb > 8.0 g/dL; or Hb change from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at two consecutive visits with available data separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (red blood cell [RBC] transfusion for all participants or darbepoetin for roxadustat treated participant). | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hb to the Average Hb of Weeks 28 to 36 Without Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (predose). | Baseline and weeks 28 to 36 |
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Inclusion Criteria:
Exclusion Criteria:
Subject has received any Erythropoiesis Stimulating Agent (ESA) treatment within 12 weeks prior to randomization.
Subject has received any dose of IV iron within 6 weeks prior to randomization.
Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization.
Subject has a known history of myelodysplastic syndrome or multiple myeloma.
Subject has a 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).
Subject has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.
Subject has a known chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.
Subject is anticipated to undergo elective surgery that is expected to lead to significant blood loss during the study period or anticipated elective coronary revascularization.
Subject has active or chronic gastrointestinal bleeding.
Subject has received any prior treatment with roxadustat or a Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
Subject has been treated with iron-chelating agents within 4 weeks prior to randomization.
Subject has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver).
Subject has known New York Heart Association Class III or IV congestive heart failure.
Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
Subject has one or more contraindications for treatment with darbepoetin alfa:
Subject has a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma as shown on renal ultrasound within 12 weeks prior to randomization.
Subject has a history of malignancy, except for the following: cancers determined to be cured or in remission for greater than or equal to 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
Subject is positive for any of the following:
Subject has an active clinically significant infection that is manifested by White Blood Count (WBC) > Upper Limit of Normal (ULN), and/or fever, in conjunction with clinical signs or symptoms of infection within one week prior to randomization.
Subject has a known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration or retinal vein occlusion.
Subject has had any prior organ transplant (that has not been explanted), subject is scheduled for organ transplantation, or subject is likely to initiate renal replacement therapy including dialysis within the first year of the study.
Subject will be excluded from participation if any of the following apply:
Subject has an anticipated use of dapsone in any dose amount or chronic use of acetaminophen/paracetamol >2.0 g/day during the treatment or follow-up period of the study.
Subject has a history of alcohol or drug abuse within 2 years prior to randomization
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site AT43009 | Vienna | Austria | ||||
| Site BY37503 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36749544 | Derived | Barratt J, Dellanna F, Portoles J, Choukroun G, De Nicola L, Young J, Dimkovic N, Reusch M. Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies. Adv Ther. 2023 Apr;40(4):1546-1559. doi: 10.1007/s12325-023-02433-0. Epub 2023 Feb 7. | |
| 36005278 |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website. | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Participants were randomized in a 1:1 ratio to roxadustat or darbepoetin alfa. Randomization was stratified by 4 factors: region, screening hemoglobin (Hb) values (Hb ≤ 8.0 g/dL versus > 8.0 g/dL), history of cardiovascular, cerebrovascular or thromboembolic diseases and screening eGFR (<30 mL/min/1.73 m^2 versus ≥30 mL/min/1.73 m^2 ).
Participants of ≥ 18 years of age with a diagnosis of chronic kidney disease, with kidney disease outcomes quality initiative stage 3, 4 or 5, anaemic and not receiving dialysis; with an estimated glomerular filtration rate (eGFR) < 60 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Roxadustat | Participants received roxadustat orally according to the tiered weight-based approach, with starting dose of 70 milligram (mg) given three times weekly (TIW) to participants weighing between 45 kilogram (kg) up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg up to 160 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for up to a maximum of 104 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2016 | Apr 18, 2021 |
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| Darbepoetin alfa |
| Drug |
Subcutaneous or intravenous injection. |
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| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 |
Baseline LDL-C was defined as the LDL-C value on day 1. If this value was missing, the latest value prior to first study drug administration was used. |
| Baseline and weeks 12 to 28 |
| Time to First Intravenous Iron Use | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to end of treatment (EOT) Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had received more than one intravenous iron, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Weeks 6, 12, 18, 24, 30 and 36 |
| Change From Baseline in Short Form-36 (SF-36) Physical Functioning (PF) Sub-Score to the Average PF Sub Score in Weeks 12 to 28 | Baseline SF-36 PF was defined as the SF-36 PF value on Day 1.The SF-36 is a Quality of Life (QoL) instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 contains 36 items that measured eight scales: (1) physical functioning; (2) role limitations due to physical health problems; (3) bodily pain; (4) social functioning; (5) general health perceptions; (6) role limitations due to emotional problems; (7) vitality, energy or fatigue; and (8) mental health. Each scale is transformed into 0-100 score, with higher scores indicating better health status. The SF-36 PF consisted of 11 questions that focused on health and ability to do usual activities, with higher scores indicating better health status. | Baseline and weeks 12 to 28 |
| Change From Baseline in SF-36 Vitality (VT) Sub-Score to the Average VT Sub-Score in Weeks 12 to 28 | Baseline VT Subscore was defined as the VT value on Day 1. The SF-36 is a QoL instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 vitality has four questions with score range from 0-100 with higher scores indicating better vitality status. | Baseline and weeks 12 to 28 |
| Change From Baseline in Mean Arterial Pressure (MAP) to the Average MAP Value in Weeks 20 to 28: Per Protocol Set | Baseline MAP was defined as the MAP value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. MAP was derived as: MAP = (2/3)*diastolic blood pressure (DBP) + (1/3)*systolic blood pressure (SBP). | Baseline and weeks 20 to 28 |
| Time to First Occurrence of Hypertension During Weeks 1 to 36: Per Protocol Set | Hypertension was defined as either SBP ≥ 170 mmHg and an increase from baseline ≥ 20 mmHg or as DBP ≥ 110 mmHg and an increase from baseline ≥ 15 mmHg. For participants who had experienced more than one event, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion. Percentage of participants were reported in this outcome measure. | Weeks 1 to 36 |
| Change From Baseline in MAP to the Average MAP Value in Weeks 20 to 28: Full Analysis Set | Baseline MAP was defined as the MAP value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. MAP was derived as: MAP = (2/3)*DBP + (1/3)*SBP. | Baseline and weeks 20 to 28 |
| Time to First Occurrence of Hypertension During Weeks 1 to 36: Full Analysis Set | Hypertension was defined as either SBP ≥ 170 mmHg and an increase from baseline ≥ 20 mmHg or as DBP ≥ 110 mmHg and an increase from baseline ≥ 15 mmHg. For participants who had experienced more than one event, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion. Percentage of participants were reported in this outcome measure. | Weeks 1 to 36 |
| Change From Baseline in Hb to the Average Hb Value of Weeks 28 to 52 Regardless of Rescue Therapy | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (pre-dose). | Baseline and weeks 28 to 52 |
| Time to First Hb Response During First 24 Weeks of Treatment Regardless of Administration of Rescue Therapy | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had experienced more than one event, only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion. Percentage of participants were reported in this outcome measure. | Weeks 1 to 24 |
| Time to First Hb Response During First 24 Weeks of Treatment Without Rescue Therapy | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had experienced more than one event, only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion. Percentage of participants were reported in this outcome measure. | Weeks 1 to 24 |
| Hb Level Averaged Over Weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 Without Rescue Therapy | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (predose). | Weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 |
| Change From Baseline in Hb to Each Postdosing Time Point Regardless Use of Rescue Therapy | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (pre-dose). | Baseline and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 |
| Change From Baseline in Hb to Average Hb Value of Weeks 28 to 36, 44 to 52, 72 to 80, 96 to 104 Regardless of Use of Rescue Therapy | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (predose). | Baseline and weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 |
| Percentage of Hb Values >=10 g/dL and Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy | Percentage for each participant was calculated from the number of Hb values within 10.0-12.0 g/dL / total number of Hb values*100 in weeks 28 to 36, 44 to 52 and 96 to 104 without use of rescue therapy within 6 weeks prior to and during the 8 week evaluation period. | Weeks 28 to 36, 44 to 52 and 96 to 104 |
| Time to First Hb Rate of Rise > 2 g/dL Within 4 Weeks | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had experienced more than one event, only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Year 0.5, 1, 1.5 and 2 |
| Number of Hospitalizations | The number of hospitalizations per participant were calculated during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). | Baseline to EOT (up to week 104) |
| Number of Days of Hospitalization Per Year | The number of days of hospitalization per year was calculated as the sum of the durations of all hospitalizations in days (minimum [date of discharge, end of efficacy of emergent period] - date of admission + 1) / (duration of efficacy emergent period in days / 365.25). The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). | Baseline to EOT (up to week 104) |
| Time to First Hospitalization | Time to first hospitalization in years was defined in years as: (first event date during the efficacy emergent period - analysis date of first dose intake +1)/365.25, and the 'first event date' was defined as 'date of first admission and 'analysis date of first dose intake. Date of end of efficacy emergent period was defined as as the treatment period up to the EOT visit. For participants who have experienced more than one hospitalization, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Year 0.5, 1, 1.5 and 2 |
| Time to First Use of RBC Transfusion | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had experienced more than one RBC transfusion, only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Year 0.5, 1, 1.5 and 2 |
| Number of RBC Packs | The number of RBC packs were calculated as the sum of units transfused during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT visit or last non-missing Hb assessment (for participants who died during the treatment period). Participants with no medication records of RBC have their number of RBC packs set to 0. | Baseline to EOT (up to week 104) |
| Volume of RBC Transfused | The volume of blood transfused was calculated as the sum of blood volume transfused during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). Participants with no medication records of RBC have their volume set to 0. | Baseline to EOT (up to week 104) |
| Number of Particpants Who Received RBC Transfusions | Participants who received RBC transfusions during the efficacy emergent period were reported. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). | Baseline to EOT (up to week 104) |
| Time to First Use of Rescue Therapy | Rescue therapy for participants in the roxadustat group included RBC transfusion or ESA therapy and for participants in the darbepoetin alfa group included RBC transfusion only. Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who have experienced more than one use of rescue therapy (i.e. RBC and ESA), only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Year 0.5, 1, 1.5 and 2 |
| Number of Participants Who Received Rescue Therapy (Composite of RBC Transfusions (All Participants) and Darbepoetin Alfa Use (Roxadustat Treated Participants Only) | Rescue therapy for participants in the roxadustat group included RBC transfusion or ESA therapy and for participants in the darbepoetin alfa group included RBC transfusion only. Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who have experienced more than one use of rescue therapy (i.e. RBC and ESA), only their first event was used. | Baseline to EOT (up to week 104) |
| Mean Monthly Intravenous Iron Per Participant During Weeks 37 to 52 and 53 to 104 | Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. | Weeks 37 to 52 and 53 to 104 |
| Time to First Use of IV Iron Supplementation | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had received more than one IV iron, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Year 0.5, 1, 1.5 and 2 |
| Percentage of Participants With Oral Iron Use Only | Percentage of participants with oral iron use only were calculated based on total number of participants within the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). | Day 1 to week 36, weeks 37 to 52, weeks 53 to 104, efficacy emergent period (up to week 104) |
| Change From Baseline to Weeks 8, 28, 52 and 104 in Total Cholesterol | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | Baseline and weeks 8, 28, 52, 104 |
| Change From Baseline to Weeks 8, 28, 52 and 104 in LDL-C/High-Density Lipoprotein Cholesterol (HDL-C) Ratio | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | Baseline and weeks 8, 28, 52, 104 |
| Change From Baseline to Weeks 8, 28, 52 and 104 in Non-HDL Cholesterol | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | Baseline and weeks 8, 28, 52, 104 |
| Change From Baseline to Weeks 8, 28, 52 and 104 in Apolipoproteins A1 (ApoA1) | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | Baseline and weeks 8, 28, 52, 104 |
| Change From Baseline to Weeks 8, 28, 52 and 104 in Apolipoproteins B (ApoB) | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | Baseline and weeks 8, 28, 52, 104 |
| Change From Baseline to Weeks 8, 28, 52 and 104 in ApoB/ApoA1 Ratio | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | Baseline and weeks 8, 28, 52, 104 |
| Number of Participants With Mean LDL Cholesterol < 100 mg/dL | Missing category for fasting only includes non-fasting participants and the participants with missing values. | Weeks 12 to 28 and 36 to 52 |
| Number of Participants Who Had Achieved Antihypertensive Treatment Goal | Achieved antihypertensive treatment goal was defined as SBP < 130 mmHg and DBP < 80 mmHg over an evaluation period defined as the average of available values in weeks 12 to 28 and 36 to 52. | Weeks 12 to 28 and 36 to 52 |
| Change From Baseline to the Average of Weeks 12 to 28 and 36 to 52 in SF-36 Physical Component Score (PCS) | Baseline SF-36 PCS was defined as the SF-36 PCS value on day 1.The SF-36 is a QoL instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 contains 36 items that measured eight scales: (1) physical functioning; (2) role limitations due to physical health problems; (3) bodily pain; (4) social functioning; (5) general health perceptions; (6) role limitations due to emotional problems; (7) vitality, energy or fatigue; and (8) mental health. Each scale is transformed into 0-100 score, with higher scores indicating better health status. The PCS was calculated based on all 8 scales and ranged from 5.02-79.78. For each of these above scales, higher scores always indicated better health status. | Baseline, weeks 12 to 28 and 36 to 52 |
| Change From Baseline to the Average of Weeks 12 to 28 and 36 to 52 in Anemia Subscale (AnS) (Additional Concerns) of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score | Baseline FACT-An AnS was defined as the FACT-An AnS value on day 1. Together with the functional assessment of cancer therapy - general (FACT-G), the AnS is referred to as the FACT-An Total. The AnS scale contains 13 fatigue specific items (the fatigue score) plus 7 items related to anemia. The Anemia AnS score range is 0 to 80. Higher scores indicated better QoL. | Baseline, weeks 12 to 28 and 36 to 52 |
| Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in FACT-An Total Score | Baseline FACT-An total score was defined on day 1. Total Fact-An score is composed of FACT-G and Ans scales. FACT-G contains 27 items that cover four dimensions of well-being: physical well being (PWB) - 7 items, functional well being (FWB) - 7 items, social/family well being (SWB) - 7 items, and emotional well being (EWB) - 6 items. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The total score was obtained by summation of the scores from PWB, SWB, EWB, FWB and AnS. The FACT-An Total Score scale range was 0-188. A higher score indicated better QoL. | Baseline, weeks 12 to 28 and 36 to 52 |
| Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in FACT-An Trial Outcome Index (TOI) Score | Baseline FACT-An total TOI Score was defined on day 1. Total FACT-An TOI score is a sum of PWB subscale score, FWB subscale score and Ans scale score. Fact-An TOI scale contains 14 items that cover four dimensions of well-being: PWB -7 items, FWB -7 items, where score range for each PWB subscale and FWB subscale is 0-28. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia, where score range for Ans scale is 0-80. The total score was obtained by summation of the scores from PWB, FWB and AnS. The FACT-An Total TOI score range was 0-136. A higher score indicated better QoL. | Baseline, weeks 12 to 28 and 36 to 52 |
| Change From Baseline to the Average Value of Weeks 12 to 28 in Euroqol Questionnaire-5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score | Baseline assessment was defined as the value on day 1. The EQ-5D-5L is a self-reported questionnaire, used as a measure of respondents' health related quality of life (HRQoL) and utility values. The EQ-5D consists of the descriptive system and the VAS. The EQ-5D descriptive system comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The VAS records the respondent's self rated health status on a graduated (0-100) scale, where the endpoints are labeled 'best imaginable health state' and 'worst imaginable health state' with higher scores for higher HRQoL. | Baseline and weeks 12 to 28 |
| Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in Work Productivity and Activity Impairment-Anemic Symptoms (WPAI:ANS) Score: Percent Work Time Missed | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to anaemic symptoms; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the anaemic symptoms on productivity while working; Q6=Impact of the anaemic symptoms on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). | Baseline, weeks 12 to 28 and 36 to 52 |
| Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Impairment While Working | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to anaemic symptoms; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the anaemic symptoms on productivity while working; Q6=Impact of the anaemic symptoms on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. Percent impairment while working due to problem: Q5/10. | Baseline, weeks 12 to 28 and 36 to 52 |
| Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Overall Work Impairment | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to anaemic symptoms; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the anaemic symptoms on productivity while working; Q6=Impact of the anaemic symptoms on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. | Baseline, weeks 12 to 28 and 36 to 52 |
| Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Activity Impairment | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to anaemic symptoms; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the anaemic symptoms on productivity while working; Q6=Impact of the anaemic symptoms on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. Percent activity impairment due to problem: Q6/10. | Baseline, weeks 12 to 28 and 36 to 52 |
| Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC) | The PGIC is a patient-rated instrument that measured change in participant's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), when compared to the start of treatment. The percentage of participants presented included very much improved, much improved and minimally improved. | Weeks 8, 12, 28, 52, 76, 104, last assessment (week 108) |
| Change From Baseline to Each Scheduled Measurement in Serum Ferritin | Baseline assessment was assessment from day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and end of study (EOS) (up to 108 weeks) |
| Change From Baseline to Each Scheduled Measurement in Transferrin Saturation (TSAT) | Baseline assessment was assessment from day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and EOS (up to 108 weeks) |
| Change From Baseline to Each Scheduled Measurement in Glycated Hemoglobin (HbA1c) | Percentage of change from baseline to each study visit were calculated for HbA1c. Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | Baseline and weeks 12, 28, 36, 44, 60, 84, 104 and EOS (up to 108 weeks) |
| Change From Baseline to Each Scheduled Measurement in Fasting Blood Glucose | Baseline assessment was assessment from day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, 106 and EOS (up to 108 weeks) |
| Change From Baseline to Each Scheduled Measurement in Estimated Glomerular Filtration Rate (eGFR) | Baseline assessment was assessment from day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, 106 and EOS (up to 108 weeks) |
| Rate of Progression of Chronic Kidney Disease Measured by eGFR Slope Over Time | Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values (one baseline and all post-treatment values up to EOT period or start of dialysis adjusted on baseline Hb, region, CV history at baseline and the interaction terms (baseline eGFR by timepoint and baseline Hb by timepoint). All assessments collected after initiation of dialysis (acute or chronic) were excluded from the analysis. Baseline assessment was the assessment from day 1 visit. If this value was missing, the value from screening visit was used. | Baseline up to EOS (up to week 108) |
| Change From Baseline to Each Scheduled Measurement in Urine Albumin/Creatinine Ratio (UACR) | Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | Baseline and weeks 12, 24, 36, 52, 64, 76, 88 and 104 |
| Time to Doubling of Serum Creatinine or Chronic Dialysis or Renal Transplant Compared to Baseline | For participants who had doubled their serum creatinine or had chronic dialysis or renal transplant more than once, only their first occurrence during safety emergent period was used. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Year 0.5, 1, 1.5 and 2 |
| Number of Participants With End Stage Renal Disease (ESRD) | Occurrence of end stage renal disease during the study (i.e from day 1 up to the end of study) was defined as at least one of the following: underwent >30 days dialysis therapy, received kidney transplant, planned kidney transplant, physician recommended renal replacement therapy and participant refused therapy, began dialysis and died < 30 days later. | Baseline up to EOS (up to week 108) |
| Time to Chronic Kidney Disease Progression (Composite of Doubling Serum Creatinine, Chronic Dialysis or Renal Transplant, and Death) | Chronic kidney disease progression was defined as date of occurrence of chronic dialysis or date of renal transplant or doubled serum creatinine or date of death, whichever came first. For participants who had chronic dialysis or renal transplant or died, only their first occurrence during the safety emergent period was used. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Year 0.5, 1, 1.5 and 2 |
| Time to Chronic Dialysis or Renal Transplant or Death | For participants who had chronic dialysis or renal transplant or died, only their first occurrence during the safety emergent period was used. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | Year 0.5, 1, 1.5 and 2 |
| Time to at Least 40% Decrease in eGFR From Baseline, Chronic Dialysis or Renal Transplant | For participants who had at least 40% decrease in eGFR from baseline, chronic dialysis or renal transplant during the safety emergent period, only their first occurrence was used. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Data reported was analyzed by kaplan-meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. | Year 0.5, 1, 1.5 and 2 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant who was given the study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment. All AEs collected during the safety emergent period were counted as TEAE. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Based on national cancer institute common terminology criteria (NCI-CTCAE), AEs were graded as grade 1=mild, grade 2=moderate, grade 3 =severe or medically significant, grade 4 =life threatening, grade 5 =death related to AE. All reported deaths after the first study drug administration and up to 28 days after the analysis date of last dose were based on last dosing frequency. | From first dose of study drug up to end of study (up to week 108) |
| Brest |
| 224027 |
| Belarus |
| Site BY37501 | Grodno | 230017 | Belarus |
| Site BY37506 | Minsk | 220036 | Belarus |
| Site BY37507 | Minsk | 220116 | Belarus |
| Site BY37505 | Minsk | 223040 | Belarus |
| Site BY37502 | Vitebsk | 210037 | Belarus |
| Site BG35907 | Sofia | 1113 | Bulgaria |
| Site BG35927 | Sofia | 1709 | Bulgaria |
| Site BG35916 | Varna | 9000 | Bulgaria |
| Site HR38505 | Karlovac | 47000 | Croatia |
| Site HR38504 | Slavonski Brod | 35000 | Croatia |
| Site HR38510 | Zagreb | 10 000 | Croatia |
| Site HR38502 | Zagreb | 10000 | Croatia |
| Site HR38509 | Zagreb | 10000 | Croatia |
| Site CZ42018 | Nový Jičín | CZ | 741 01 | Czechia |
| Site CZ42008 | Liberec | 46063 | Czechia |
| Site CZ42021 | Prague | Czechia |
| Site FI35810 | Helsinki | 290 | Finland |
| Site FR33004 | Avignon | 84900 | France |
| Site FR33009 | Colmar | 68024 | France |
| Site FR33010 | Grenoble | France |
| Site FR33062 | Limoges | 87042 | France |
| Site FR33012 | Lyon | 69437 | France |
| Site FR33007 | Saint-Priest-en-Jarez | 42270 | France |
| Site GE99503 | Tbilisi | 144 | Georgia |
| Site GE99504 | Tbilisi | 144 | Georgia |
| Site GE99502 | Tbilisi | 159 | Georgia |
| Site DE49073 | Cloppenburg | 49661 | Germany |
| Site DE49054 | Düsseldorf | 40210 | Germany |
| Site DE49065 | Hamburg | 23397 | Germany |
| Site DE49075 | Heilbronn | 74076 | Germany |
| Site DE49057 | Hoyerswerda | 02977 | Germany |
| Site HU36028 | Budapest | 1097 | Hungary |
| Site HU36029 | Budapest | Hungary |
| Site HU36027 | Kistarcsa | 2143 | Hungary |
| Site HU36008 | Pécs | H 7624 | Hungary |
| Site HU36046 | Velence | Hungary |
| Site IE35301 | Cork | Ireland |
| Site IL97202 | Be’er Ya‘aqov | 70300 | Israel |
| Site IL97215 | Haifa | 34362 | Israel |
| Site LV37101 | Riga | LV-1002 | Latvia |
| Site LV37104 | Ventspils | LV-3601 | Latvia |
| Site ME38202 | Nikšić | 81400 | Montenegro |
| Site ME38201 | Podgorica | 81000 | Montenegro |
| Site NL31005 | Utrecht | 3584 CX | Netherlands |
| Site MK38901 | Skopje | 1000 | North Macedonia |
| Site MK38903 | Struga | 6330 | North Macedonia |
| Site PL48001 | Krakow | 31-559 | Poland |
| Site PL48066 | Puławy | 24-100 | Poland |
| Site PL48013 | Szczecin | 70-111 | Poland |
| Site PL48007 | Tarnów | 33-100 | Poland |
| Site PL48004 | Warsaw | 04-749 | Poland |
| Site PL48009 | Wroclaw | Poland |
| Site PL48059 | Zamość | 22-400 | Poland |
| Site PT35120 | Almada | 2801-951 | Portugal |
| Site PT35131 | Braga | 4710-243 | Portugal |
| Site PT35112 | Carnaxide | 2795-523 | Portugal |
| Site PT35119 | Evora | 7000-811 | Portugal |
| Site PT35118 | Lisbon | 1069-166 | Portugal |
| Site PT35133 | Matosinhos Municipality | 4464-513 | Portugal |
| Site PT35122 | Setúbal | 2910-446 | Portugal |
| Site PT35132 | Vila Nova de Gaia | 4434-502 | Portugal |
| Site RO40012 | Bucharest | 10825 | Romania |
| Site RO40003 | Bucharest | 11234 | Romania |
| Site RO40021 | Bucharest | 22328 | Romania |
| Site RO40004 | Oradea | 410469 | Romania |
| Site RU70024 | Chelyabinsk | 454047 | Russia |
| Site RU70054 | Irkutsk | 664079 | Russia |
| Site RU70047 | Moscow | 119992 | Russia |
| Site RU70006 | Moscow | 125284 | Russia |
| Site RU70003 | Nizhny Novgorod | 603032 | Russia |
| Site RU70004 | Omsk | 644112 | Russia |
| Site RU70014 | Rostov-on-Don | 344029 | Russia |
| Site RU70011 | Saint Petersburg | 196247 | Russia |
| Site RU70002 | Saint Petersburg | 197089 | Russia |
| Site RU70060 | Saratov | 410039 | Russia |
| Site RU70057 | Yaroslavl | 150000 | Russia |
| Site RU70001 | Yaroslavl | 150062 | Russia |
| Site RS38102 | Belgrade | 11000 | Serbia |
| Site RS38105 | Belgrade | 11000 | Serbia |
| Site RS38103 | Belgrade | 11080 | Serbia |
| Site RS38104 | Belgrade | Serbia |
| Site RS38117 | Kruševac | 37000 | Serbia |
| Site RS38101 | Niš | 11070 | Serbia |
| Site SK42102 | Košice | 04001 | Slovakia |
| Site SK42109 | Košice | 04001 | Slovakia |
| Site SK42113 | Púchov | 02001 | Slovakia |
| Site SK42116 | Senica | 905 01 | Slovakia |
| Site SI38615 | Jesenice | SI-4270 | Slovenia |
| Site SI38603 | Maribor | 2000 | Slovenia |
| Site SI38609 | Sempeter pri Gorici | 5290 | Slovenia |
| Site SI38619 | Slovenj Gradec | SI 2380 | Slovenia |
| Site ES34049 | Ferrol | A Coruna | 15405 | Spain |
| Site ES34026 | Barcelona | 08907 | Spain |
| Site ES34039 | Córdoba | 14004 | Spain |
| Site ES34054 | Girona | 17007 | Spain |
| Site ES34017 | Jaén | 23007 | Spain |
| Site ES34037 | Madrid | 28046 | Spain |
| Site ES34010 | Madrid | 28922 | Spain |
| Site ES34030 | Majadahonda | 28222 | Spain |
| Site ES34041 | Santiago de Compostela | 15706 | Spain |
| Site UA38009 | Lviv | Lvivska | 79010 | Ukraine |
| Site UA38021 | Cherkasy | 18009 | Ukraine |
| Site UA38006 | Dnipropetrovsk | 49005 | Ukraine |
| Site UA38016 | Ivano-Frankivsk | 76018 | Ukraine |
| Site UA38011 | Kharkiv | 61103 | Ukraine |
| Site UA38017 | Kiev | 4053 | Ukraine |
| Site UA38007 | Mykolaiv | Ukraine |
| Site UA38008 | Odesa | 6500 | Ukraine |
| Site UA38001 | Ternopil | 46002 | Ukraine |
| Site UA38018 | Uzhhorod | 88018 | Ukraine |
| Site GB44098 | Dorchester | Dorset | DT1 2JY | United Kingdom |
| Site GB44064 | Birmingham | B9 5SS | United Kingdom |
| Site GB44099 | Dartford | DA2 8DA | United Kingdom |
| Site GB44102 | Kings Lynn | PE30 4ET | United Kingdom |
| Site GB44081 | Leicester | LE5 4PW | United Kingdom |
| Site GB44086 | London | E1 1BB | United Kingdom |
| Site GB44006 | London | SE5 9RS | United Kingdom |
| Site GB44082 | London | SW17 0QT | United Kingdom |
| Site GB44097 | Nottingham | NG5 1PB | United Kingdom |
| Site GB44100 | Orpington | BR6 8ND | United Kingdom |
| Site GB44101 | Preston | PR2 9HT | United Kingdom |
| Site GB44080 | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Site GB44001 | Swansea | SA6 6NL | United Kingdom |
| Derived |
| Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. |
| FG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 microgram per kilogram [μg/kg] of body weight, as a single subcutaneous or intravenous [IV] injection once weekly or 0.75 μg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per European Summary of Product Characteristics (EU SmPC) along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 grams per deciliter (g/dL) and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis population was the safety analysis set which consisted of all randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Roxadustat | Participants received roxadustat orally according to the tiered weight-based approach, with starting dose of 70 mg given TIW to participants weighing between 45 kg up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg up to 160 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for up to a maximum of 104 weeks. |
| BG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 μg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 μg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Baseline Hb Value | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy | Hb response was measured as Yes or No. Response Yes (responders) was defined as: Hb ≥11.0 g/dL and Hb change from baseline by ≥ 1.0 g/dL, for participants with baseline Hb > 8.0 g/dL; or Hb change from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at two consecutive visits with available data separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (red blood cell [RBC] transfusion for all participants or darbepoetin for roxadustat treated participant). | The analysis population was the Per Protocol Set (PPS) which consisted of all Full Analysis Set (FAS) participants who did not meet any of exclusion criteria from the PPS. The FAS consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose valid Hb assessment. | Posted | Number | Percentage of Participants | Baseline to week 24 |
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| Secondary | Change From Baseline in Hb to the Average Hb of Weeks 28 to 36 Without Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (predose). | The analysis population was the PPS, with participants who had available data. | Posted | Mean | Standard Deviation | g/dL | Baseline and weeks 28 to 36 |
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| Secondary | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | Baseline LDL-C was defined as the LDL-C value on day 1. If this value was missing, the latest value prior to first study drug administration was used. | The analysis population was the FAS, with participants who had available data. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline and weeks 12 to 28 |
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| Secondary | Time to First Intravenous Iron Use | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to end of treatment (EOT) Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had received more than one intravenous iron, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Weeks 6, 12, 18, 24, 30 and 36 |
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| Secondary | Change From Baseline in Short Form-36 (SF-36) Physical Functioning (PF) Sub-Score to the Average PF Sub Score in Weeks 12 to 28 | Baseline SF-36 PF was defined as the SF-36 PF value on Day 1.The SF-36 is a Quality of Life (QoL) instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 contains 36 items that measured eight scales: (1) physical functioning; (2) role limitations due to physical health problems; (3) bodily pain; (4) social functioning; (5) general health perceptions; (6) role limitations due to emotional problems; (7) vitality, energy or fatigue; and (8) mental health. Each scale is transformed into 0-100 score, with higher scores indicating better health status. The SF-36 PF consisted of 11 questions that focused on health and ability to do usual activities, with higher scores indicating better health status. | The analysis population was the PPS, with participants who had available data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and weeks 12 to 28 |
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| Secondary | Change From Baseline in SF-36 Vitality (VT) Sub-Score to the Average VT Sub-Score in Weeks 12 to 28 | Baseline VT Subscore was defined as the VT value on Day 1. The SF-36 is a QoL instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 vitality has four questions with score range from 0-100 with higher scores indicating better vitality status. | The analysis population was the PPS, with participants who had available data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and weeks 12 to 28 |
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| Secondary | Change From Baseline in Mean Arterial Pressure (MAP) to the Average MAP Value in Weeks 20 to 28: Per Protocol Set | Baseline MAP was defined as the MAP value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. MAP was derived as: MAP = (2/3)*diastolic blood pressure (DBP) + (1/3)*systolic blood pressure (SBP). | The analysis population was the PPS, with participants who had available data. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline and weeks 20 to 28 |
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| Secondary | Time to First Occurrence of Hypertension During Weeks 1 to 36: Per Protocol Set | Hypertension was defined as either SBP ≥ 170 mmHg and an increase from baseline ≥ 20 mmHg or as DBP ≥ 110 mmHg and an increase from baseline ≥ 15 mmHg. For participants who had experienced more than one event, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion. Percentage of participants were reported in this outcome measure. | The analysis population was the PPS. | Posted | Number | Percentage of Participants | Weeks 1 to 36 |
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| Secondary | Change From Baseline in MAP to the Average MAP Value in Weeks 20 to 28: Full Analysis Set | Baseline MAP was defined as the MAP value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. MAP was derived as: MAP = (2/3)*DBP + (1/3)*SBP. | The analysis population was the FAS, with participants who had available data. | Posted | Mean | Standard Deviation | mmHg | Baseline and weeks 20 to 28 |
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| Secondary | Time to First Occurrence of Hypertension During Weeks 1 to 36: Full Analysis Set | Hypertension was defined as either SBP ≥ 170 mmHg and an increase from baseline ≥ 20 mmHg or as DBP ≥ 110 mmHg and an increase from baseline ≥ 15 mmHg. For participants who had experienced more than one event, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | Percentage of Participants | Weeks 1 to 36 |
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| Secondary | Change From Baseline in Hb to the Average Hb Value of Weeks 28 to 52 Regardless of Rescue Therapy | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (pre-dose). | The analysis population was the FAS, with participants who had available data. | Posted | Mean | Standard Deviation | g/dL | Baseline and weeks 28 to 52 |
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| Secondary | Time to First Hb Response During First 24 Weeks of Treatment Regardless of Administration of Rescue Therapy | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had experienced more than one event, only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | Percentage of Participants | Weeks 1 to 24 |
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| Secondary | Time to First Hb Response During First 24 Weeks of Treatment Without Rescue Therapy | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had experienced more than one event, only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | Percentage of participants | Weeks 1 to 24 |
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| Secondary | Hb Level Averaged Over Weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 Without Rescue Therapy | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (predose). | The analysis population was the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | g/dL | Weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 |
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| Secondary | Change From Baseline in Hb to Each Postdosing Time Point Regardless Use of Rescue Therapy | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (pre-dose). | The analysis population was the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | g/dL | Baseline and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104 |
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| Secondary | Change From Baseline in Hb to Average Hb Value of Weeks 28 to 36, 44 to 52, 72 to 80, 96 to 104 Regardless of Use of Rescue Therapy | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (predose). | The analysis population was the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | g/dL | Baseline and weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 |
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| Secondary | Percentage of Hb Values >=10 g/dL and Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy | Percentage for each participant was calculated from the number of Hb values within 10.0-12.0 g/dL / total number of Hb values*100 in weeks 28 to 36, 44 to 52 and 96 to 104 without use of rescue therapy within 6 weeks prior to and during the 8 week evaluation period. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Percentage of Hb values | Weeks 28 to 36, 44 to 52 and 96 to 104 |
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| Secondary | Time to First Hb Rate of Rise > 2 g/dL Within 4 Weeks | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had experienced more than one event, only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Year 0.5, 1, 1.5 and 2 |
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| Secondary | Number of Hospitalizations | The number of hospitalizations per participant were calculated during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Hospitalizations | Baseline to EOT (up to week 104) |
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| Secondary | Number of Days of Hospitalization Per Year | The number of days of hospitalization per year was calculated as the sum of the durations of all hospitalizations in days (minimum [date of discharge, end of efficacy of emergent period] - date of admission + 1) / (duration of efficacy emergent period in days / 365.25). The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Days per year | Baseline to EOT (up to week 104) |
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| Secondary | Time to First Hospitalization | Time to first hospitalization in years was defined in years as: (first event date during the efficacy emergent period - analysis date of first dose intake +1)/365.25, and the 'first event date' was defined as 'date of first admission and 'analysis date of first dose intake. Date of end of efficacy emergent period was defined as as the treatment period up to the EOT visit. For participants who have experienced more than one hospitalization, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Year 0.5, 1, 1.5 and 2 |
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| Secondary | Time to First Use of RBC Transfusion | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had experienced more than one RBC transfusion, only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Year 0.5, 1, 1.5 and 2 |
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| Secondary | Number of RBC Packs | The number of RBC packs were calculated as the sum of units transfused during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT visit or last non-missing Hb assessment (for participants who died during the treatment period). Participants with no medication records of RBC have their number of RBC packs set to 0. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | RBC packs | Baseline to EOT (up to week 104) |
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| Secondary | Volume of RBC Transfused | The volume of blood transfused was calculated as the sum of blood volume transfused during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). Participants with no medication records of RBC have their volume set to 0. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | mL | Baseline to EOT (up to week 104) |
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| Secondary | Number of Particpants Who Received RBC Transfusions | Participants who received RBC transfusions during the efficacy emergent period were reported. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). | The analysis population was the FAS. | Posted | Count of Participants | Participants | Baseline to EOT (up to week 104) |
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| Secondary | Time to First Use of Rescue Therapy | Rescue therapy for participants in the roxadustat group included RBC transfusion or ESA therapy and for participants in the darbepoetin alfa group included RBC transfusion only. Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who have experienced more than one use of rescue therapy (i.e. RBC and ESA), only their first event was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Year 0.5, 1, 1.5 and 2 |
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| Secondary | Number of Participants Who Received Rescue Therapy (Composite of RBC Transfusions (All Participants) and Darbepoetin Alfa Use (Roxadustat Treated Participants Only) | Rescue therapy for participants in the roxadustat group included RBC transfusion or ESA therapy and for participants in the darbepoetin alfa group included RBC transfusion only. Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who have experienced more than one use of rescue therapy (i.e. RBC and ESA), only their first event was used. | The analysis population was the FAS. | Posted | Count of Participants | Participants | Baseline to EOT (up to week 104) |
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| Secondary | Mean Monthly Intravenous Iron Per Participant During Weeks 37 to 52 and 53 to 104 | Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | mg per month | Weeks 37 to 52 and 53 to 104 |
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| Secondary | Time to First Use of IV Iron Supplementation | Participants were analyzed during the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). For participants who had received more than one IV iron, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Year 0.5, 1, 1.5 and 2 |
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| Secondary | Percentage of Participants With Oral Iron Use Only | Percentage of participants with oral iron use only were calculated based on total number of participants within the efficacy emergent period. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). | The analysis population was the FAS. | Posted | Number | Percentage of Participants | Day 1 to week 36, weeks 37 to 52, weeks 53 to 104, efficacy emergent period (up to week 104) |
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| Secondary | Change From Baseline to Weeks 8, 28, 52 and 104 in Total Cholesterol | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | mmol/L | Baseline and weeks 8, 28, 52, 104 |
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| Secondary | Change From Baseline to Weeks 8, 28, 52 and 104 in LDL-C/High-Density Lipoprotein Cholesterol (HDL-C) Ratio | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Ratio | Baseline and weeks 8, 28, 52, 104 |
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| Secondary | Change From Baseline to Weeks 8, 28, 52 and 104 in Non-HDL Cholesterol | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | mmoL/L | Baseline and weeks 8, 28, 52, 104 |
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| Secondary | Change From Baseline to Weeks 8, 28, 52 and 104 in Apolipoproteins A1 (ApoA1) | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline and weeks 8, 28, 52, 104 |
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| Secondary | Change From Baseline to Weeks 8, 28, 52 and 104 in Apolipoproteins B (ApoB) | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) | Baseline and weeks 8, 28, 52, 104 |
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| Secondary | Change From Baseline to Weeks 8, 28, 52 and 104 in ApoB/ApoA1 Ratio | Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Ratio | Baseline and weeks 8, 28, 52, 104 |
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| Secondary | Number of Participants With Mean LDL Cholesterol < 100 mg/dL | Missing category for fasting only includes non-fasting participants and the participants with missing values. | The analysis population was the FAS. | Posted | Count of Participants | Participants | Weeks 12 to 28 and 36 to 52 |
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| Secondary | Number of Participants Who Had Achieved Antihypertensive Treatment Goal | Achieved antihypertensive treatment goal was defined as SBP < 130 mmHg and DBP < 80 mmHg over an evaluation period defined as the average of available values in weeks 12 to 28 and 36 to 52. | The analysis population was the FAS. | Posted | Count of Participants | Participants | Weeks 12 to 28 and 36 to 52 |
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| Secondary | Change From Baseline to the Average of Weeks 12 to 28 and 36 to 52 in SF-36 Physical Component Score (PCS) | Baseline SF-36 PCS was defined as the SF-36 PCS value on day 1.The SF-36 is a QoL instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 contains 36 items that measured eight scales: (1) physical functioning; (2) role limitations due to physical health problems; (3) bodily pain; (4) social functioning; (5) general health perceptions; (6) role limitations due to emotional problems; (7) vitality, energy or fatigue; and (8) mental health. Each scale is transformed into 0-100 score, with higher scores indicating better health status. The PCS was calculated based on all 8 scales and ranged from 5.02-79.78. For each of these above scales, higher scores always indicated better health status. | The analysis population was the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, weeks 12 to 28 and 36 to 52 |
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| Secondary | Change From Baseline to the Average of Weeks 12 to 28 and 36 to 52 in Anemia Subscale (AnS) (Additional Concerns) of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score | Baseline FACT-An AnS was defined as the FACT-An AnS value on day 1. Together with the functional assessment of cancer therapy - general (FACT-G), the AnS is referred to as the FACT-An Total. The AnS scale contains 13 fatigue specific items (the fatigue score) plus 7 items related to anemia. The Anemia AnS score range is 0 to 80. Higher scores indicated better QoL. | The analysis population was the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, weeks 12 to 28 and 36 to 52 |
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| Secondary | Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in FACT-An Total Score | Baseline FACT-An total score was defined on day 1. Total Fact-An score is composed of FACT-G and Ans scales. FACT-G contains 27 items that cover four dimensions of well-being: physical well being (PWB) - 7 items, functional well being (FWB) - 7 items, social/family well being (SWB) - 7 items, and emotional well being (EWB) - 6 items. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The total score was obtained by summation of the scores from PWB, SWB, EWB, FWB and AnS. The FACT-An Total Score scale range was 0-188. A higher score indicated better QoL. | The analysis population was the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, weeks 12 to 28 and 36 to 52 |
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| Secondary | Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in FACT-An Trial Outcome Index (TOI) Score | Baseline FACT-An total TOI Score was defined on day 1. Total FACT-An TOI score is a sum of PWB subscale score, FWB subscale score and Ans scale score. Fact-An TOI scale contains 14 items that cover four dimensions of well-being: PWB -7 items, FWB -7 items, where score range for each PWB subscale and FWB subscale is 0-28. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia, where score range for Ans scale is 0-80. The total score was obtained by summation of the scores from PWB, FWB and AnS. The FACT-An Total TOI score range was 0-136. A higher score indicated better QoL. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, weeks 12 to 28 and 36 to 52 |
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| Secondary | Change From Baseline to the Average Value of Weeks 12 to 28 in Euroqol Questionnaire-5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score | Baseline assessment was defined as the value on day 1. The EQ-5D-5L is a self-reported questionnaire, used as a measure of respondents' health related quality of life (HRQoL) and utility values. The EQ-5D consists of the descriptive system and the VAS. The EQ-5D descriptive system comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The VAS records the respondent's self rated health status on a graduated (0-100) scale, where the endpoints are labeled 'best imaginable health state' and 'worst imaginable health state' with higher scores for higher HRQoL. | The analysis population was the FAS, with participants who had available data. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline and weeks 12 to 28 |
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| Secondary | Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in Work Productivity and Activity Impairment-Anemic Symptoms (WPAI:ANS) Score: Percent Work Time Missed | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to anaemic symptoms; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the anaemic symptoms on productivity while working; Q6=Impact of the anaemic symptoms on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). | The analysis population was the FAS, with participants who had available data. | Posted | Mean | Standard Deviation | Percent work time | Baseline, weeks 12 to 28 and 36 to 52 |
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| Secondary | Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Impairment While Working | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to anaemic symptoms; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the anaemic symptoms on productivity while working; Q6=Impact of the anaemic symptoms on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. Percent impairment while working due to problem: Q5/10. | The analysis population was the FAS, with participants who had available data. | Posted | Mean | Standard Deviation | Percent impairment | Baseline, weeks 12 to 28 and 36 to 52 |
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| Secondary | Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Overall Work Impairment | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to anaemic symptoms; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the anaemic symptoms on productivity while working; Q6=Impact of the anaemic symptoms on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. | The analysis population was the FAS, with participants who had available data. | Posted | Mean | Standard Deviation | Percent impairment | Baseline, weeks 12 to 28 and 36 to 52 |
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| Secondary | Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Activity Impairment | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to anaemic symptoms; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the anaemic symptoms on productivity while working; Q6=Impact of the anaemic symptoms on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. Percent activity impairment due to problem: Q6/10. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Percent impairment | Baseline, weeks 12 to 28 and 36 to 52 |
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| Secondary | Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC) | The PGIC is a patient-rated instrument that measured change in participant's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), when compared to the start of treatment. The percentage of participants presented included very much improved, much improved and minimally improved. | The analysis population was the FAS. | Posted | Number | Percentage of Participants | Weeks 8, 12, 28, 52, 76, 104, last assessment (week 108) |
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| Secondary | Change From Baseline to Each Scheduled Measurement in Serum Ferritin | Baseline assessment was assessment from day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Picomoles per liter (pmol/L) | Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and end of study (EOS) (up to 108 weeks) |
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| Secondary | Change From Baseline to Each Scheduled Measurement in Transferrin Saturation (TSAT) | Baseline assessment was assessment from day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Percentage of saturation | Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and EOS (up to 108 weeks) |
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| Secondary | Change From Baseline to Each Scheduled Measurement in Glycated Hemoglobin (HbA1c) | Percentage of change from baseline to each study visit were calculated for HbA1c. Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | Percentage of HbA1c | Baseline and weeks 12, 28, 36, 44, 60, 84, 104 and EOS (up to 108 weeks) |
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| Secondary | Change From Baseline to Each Scheduled Measurement in Fasting Blood Glucose | Baseline assessment was assessment from day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | The analysis population was the FAS. | Posted | Mean | Standard Deviation | mg/dL | Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, 106 and EOS (up to 108 weeks) |
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| Secondary | Change From Baseline to Each Scheduled Measurement in Estimated Glomerular Filtration Rate (eGFR) | Baseline assessment was assessment from day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | The analysis population was the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean ratio | Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, 106 and EOS (up to 108 weeks) |
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| Secondary | Rate of Progression of Chronic Kidney Disease Measured by eGFR Slope Over Time | Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values (one baseline and all post-treatment values up to EOT period or start of dialysis adjusted on baseline Hb, region, CV history at baseline and the interaction terms (baseline eGFR by timepoint and baseline Hb by timepoint). All assessments collected after initiation of dialysis (acute or chronic) were excluded from the analysis. Baseline assessment was the assessment from day 1 visit. If this value was missing, the value from screening visit was used. | The analysis population was the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | ml/min per 1.73 m^2 | Baseline up to EOS (up to week 108) |
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| Secondary | Change From Baseline to Each Scheduled Measurement in Urine Albumin/Creatinine Ratio (UACR) | Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. | The analysis population was the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean ratio | Baseline and weeks 12, 24, 36, 52, 64, 76, 88 and 104 |
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| Secondary | Time to Doubling of Serum Creatinine or Chronic Dialysis or Renal Transplant Compared to Baseline | For participants who had doubled their serum creatinine or had chronic dialysis or renal transplant more than once, only their first occurrence during safety emergent period was used. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Year 0.5, 1, 1.5 and 2 |
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| Secondary | Number of Participants With End Stage Renal Disease (ESRD) | Occurrence of end stage renal disease during the study (i.e from day 1 up to the end of study) was defined as at least one of the following: underwent >30 days dialysis therapy, received kidney transplant, planned kidney transplant, physician recommended renal replacement therapy and participant refused therapy, began dialysis and died < 30 days later. | The analysis population was the FAS. | Posted | Count of Participants | Participants | Baseline up to EOS (up to week 108) |
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| Secondary | Time to Chronic Kidney Disease Progression (Composite of Doubling Serum Creatinine, Chronic Dialysis or Renal Transplant, and Death) | Chronic kidney disease progression was defined as date of occurrence of chronic dialysis or date of renal transplant or doubled serum creatinine or date of death, whichever came first. For participants who had chronic dialysis or renal transplant or died, only their first occurrence during the safety emergent period was used. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Year 0.5, 1, 1.5 and 2 |
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| Secondary | Time to Chronic Dialysis or Renal Transplant or Death | For participants who had chronic dialysis or renal transplant or died, only their first occurrence during the safety emergent period was used. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. Percentage of participants were reported in this outcome measure. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Year 0.5, 1, 1.5 and 2 |
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| Secondary | Time to at Least 40% Decrease in eGFR From Baseline, Chronic Dialysis or Renal Transplant | For participants who had at least 40% decrease in eGFR from baseline, chronic dialysis or renal transplant during the safety emergent period, only their first occurrence was used. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Data reported was analyzed by kaplan-meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. | The analysis population was the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Year 0.5, 1, 1.5 and 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant who was given the study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment. All AEs collected during the safety emergent period were counted as TEAE. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments. Based on national cancer institute common terminology criteria (NCI-CTCAE), AEs were graded as grade 1=mild, grade 2=moderate, grade 3 =severe or medically significant, grade 4 =life threatening, grade 5 =death related to AE. All reported deaths after the first study drug administration and up to 28 days after the analysis date of last dose were based on last dosing frequency. | The analysis population was the safety analysis set included all randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug up to end of study (up to week 108) |
|
From first dose of study drug up to end of study (up to week 108)
Total number of deaths (all causes) includes deaths reported after the time frame above. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the end of treatment taking into account the different dosing frequencies of the study treatments.
Not provided
| 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 orally according to the tiered weight-based approach, with starting dose of 70 mg given TIW to participants weighing between 45 kg up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg up to 160 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for up to a maximum of 104 weeks. | 40 | 323 | 209 | 323 | 223 | 323 |
| EG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 μg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 μg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. | 37 | 293 | 181 | 293 | 203 | 293 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypocoagulable state | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Long QT syndrome | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Myocardial fibrosis | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Nodal arrhythmia | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Trifascicular block | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 20 | Systematic Assessment |
| |
| Lown-Ganong-Levine syndrome | Congenital, familial and genetic disorders | MedDRA 20 | Systematic Assessment |
| |
| Spinocerebellar ataxia | Congenital, familial and genetic disorders | MedDRA 20 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 20 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 20 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 20 | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA 20 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 20 | Systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Bloody peritoneal effluent | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastric antral vascular ectasia | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Reactive gastropathy | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 20 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Hepatic congestion | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
| |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 20 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 20 | Systematic Assessment |
| |
| Renal transplant failure | Immune system disorders | MedDRA 20 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 20 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Acute hepatitis B | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Hepatic cyst infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Renal cyst infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Streptococcal endocarditis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Arterial bypass occlusion | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Arteriovenous fistula site haematoma | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Peritoneal dialysis complication | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Urinary anastomotic leak | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Vascular access malfunction | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Vascular access site bruising | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Vascular access site swelling | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Vascular access site thrombosis | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 20 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 20 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 20 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 20 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 20 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 20 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 20 | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA 20 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Alkalosis hypochloraemic | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Mineral deficiency | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Benign renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Carcinoma in situ of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Uterine neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Simple partial seizures | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Uraemic encephalopathy | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 20 | Systematic Assessment |
| |
| Device leakage | Product Issues | MedDRA 20 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
| |
| Frustration tolerance decreased | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Renal cyst ruptured | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Urinary bladder rupture | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 20 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 20 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Bronchopulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pulmonary vasculitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Aortic intramural haematoma | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Blood pressure fluctuation | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 20 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 20 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 20 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study after Sponsor publication of multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Astellas Pharma Europe B.V. | +44 (0)20 3379 8000 | Astellas.resultsdisclosure@astellas.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2018 | Apr 18, 2021 | SAP_003.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| 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 |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C584543 | roxadustat |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| >8.0 g/dL |
|
|
|
|
|
|
|
| OG001 |
| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
|
|
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks.
|
|
| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
|
|
|
|
|
|
| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
|
| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
|
|
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
|
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| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight (either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks) as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| OG001 |
| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| OG001 |
| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| Darbepoetin Alfa |
Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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| OG001 | Darbepoetin Alfa | Participants received initial dose of darbepoetin alfa based upon the weight [either 0.45 mcg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 mcg/kg of body weight, as a single subcutaneous injection once every 2 weeks] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of >= 11.0 g/dL and Hb increase from baseline of >= 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks. |
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