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This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-ep [Mircera] | Drug | As prescribed by physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented. | Month 0 to Month 12 |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented. | Month 0 to Month 12 |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented. | Month 6 to Month 12 |
| Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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CKD patients treated with Mirecera at different medical centers
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saarlouis | 66740 | Germany |
Data of this non-interventional study were analyzed by the following strata: predialysis participants versus hemodialysis participants, unless otherwise specified.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) | Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): all participants for whom at least one hemoglobin value after the first application of methoxy polyethylene glycol-epoetin beta during the study course was documented.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented. | FAS | Posted | Number | percentage of participants | Month 0 to Month 12 |
|
Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
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 | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolysis | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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| Month 0 to Month 12 |
| Serum Ferritin Values | Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
| Serum Iron Values | Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
| Transferrin Values | Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
| Transferrin Saturation Values | Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
| C-reactive Protein (CRP) Values | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
| Number of Physicians Satisfied With Treatment at Final Visit | Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation |
| Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion | At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation |
| Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation |
| Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation |
| Number of Participants Satisfied With Treatment at Final Visit | Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Death |
|
| Hospitalization |
|
| Other |
|
| Missing |
|
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) |
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. |
|
|
| Primary | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented. | FAS. n = participants evaluable for specified category for each arm group, respectively. | Posted | Number | percentage of participants | Month 0 to Month 12 |
|
|
|
| Primary | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented. | FAS. n = participants evaluable for specified category for each arm group, respectively. | Posted | Number | percentage of participants | Month 6 to Month 12 |
|
|
|
| Primary | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category. | Posted | Mean | Standard Deviation | g/dL | Month 0 to Month 12 |
|
|
|
| Primary | Serum Ferritin Values | Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint. | Posted | Mean | Standard Deviation | ng/mL | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
|
|
|
| Primary | Serum Iron Values | Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint. | Posted | Mean | Standard Deviation | mcg/dL | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
|
|
|
| Primary | Transferrin Values | Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint. | Posted | Mean | Standard Deviation | mg/dL | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
|
|
|
| Primary | Transferrin Saturation Values | Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint. | Posted | Mean | Standard Deviation | percent transferrin saturation | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
|
|
|
| Primary | C-reactive Protein (CRP) Values | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint. | Posted | Mean | Standard Deviation | mg/dL | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
|
|
|
| Primary | Number of Physicians Satisfied With Treatment at Final Visit | Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants. | FAS | Posted | Number | physicians | Month 12 or early discontinuation |
|
|
|
| Primary | Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion | At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants. | FAS | Posted | Number | participants | Month 12 or early discontinuation |
|
|
|
| Primary | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. | Posted | Number | participants | Month 12 or early discontinuation |
|
|
|
| Primary | Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. | Posted | Number | participants | Month 12 or early discontinuation |
|
|
|
| Primary | Number of Participants Satisfied With Treatment at Final Visit | Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". Data for this outcome measure was reported for overall participants. | FAS | Posted | Number | participants | Month 12 or early discontinuation |
|
|
|
| Secondary | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants. | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during each timepoint. | Posted | Mean | Standard Deviation | mcg | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
|
|
|
| 7 |
| 346 |
| 13 |
| 346 |
| EG001 | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. | 67 | 1,201 | 196 | 1,201 |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastrointestinal angiodysplasia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Ulcer haemorrhage | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Psoas abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Amputation | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
|
| Arteriovenous shunt operation | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
|
| Nephrectomy | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| No dose modifications: Hb 11-13 g/dL (n=157, 242) |
|
| With dose modifications: Hb 10-12g/dL (n=169, 942) |
|
| With dose modifications: Hb 11-12g/dL (n=169, 942) |
|
| With dose modifications: Hb 11-13g/dL (n=169, 942) |
|
| Age <65 years: Hb 10-12 g/dL (n=70, 402) |
|
| Age <65 years: Hb 11-12 g/dL (n=70, 402) |
|
| Age <65 years: Hb 11-13 g/dL (n=70, 402) |
|
| Age >=65 years: Hb 10-12 g/dL (n=256, 782) |
|
| Age >=65 years: Hb 11-12 g/dL (n=256, 782) |
|
| Age >=65 years: Hb 11-13 g/dL (n=256, 782) |
|
| Center size >100: Hb 10-12 g/dL (n=99, 563) |
|
| Center size >100: Hb 11-12 g/dL (n=99, 563) |
|
| Center size >100: Hb 11-13 g/dL (n=99, 563) |
|
| Center size <=100: Hb 10-12 g/dL (n=227, 621) |
|
| Center size <=100: Hb 11-12 g/dL (n=227, 621) |
|
| Center size <=100: Hb 11-13 g/dL (n=227, 621) |
|
| No dose modifications: Hb 11-13 g/dL (n=157, 242) |
|
| With dose modifications: Hb 10-12g/dL (n=169, 942) |
|
| With dose modifications: Hb 11-12g/dL (n=169, 942) |
|
| With dose modifications: Hb 11-13g/dL (n=169, 942) |
|
| Age <65 years: Hb 10-12 g/dL (n=70, 402) |
|
| Age <65 years: Hb 11-12 g/dL (n=70, 402) |
|
| Age <65 years: Hb 11-13 g/dL (n=70, 402) |
|
| Age >=65 years: Hb 10-12 g/dL (n=256, 782) |
|
| Age >=65 years: Hb 11-12 g/dL (n=256, 782) |
|
| Age >=65 years: Hb 11-13 g/dL (n=256, 782) |
|
| Center size >100: Hb 10-12 g/dL (n=99, 563) |
|
| Center size >100: Hb 11-12 g/dL (n=99, 563) |
|
| Center size >100: Hb 11-13 g/dL (n=99, 563) |
|
| Center size <=100: Hb 10-12 g/dL (n=227, 621) |
|
| Center size <=100: Hb 11-12 g/dL (n=227, 621) |
|
| Center size <=100: Hb 11-13 g/dL (n=227, 621) |
|
| Title | Measurements |
|---|---|
|
| Age >=65 years (n=1022) |
|
| Center size >100 participants (n=654) |
|
| Center size <=100 participants (n=835) |
|
| Title | Measurements |
|---|---|
|
| Month 3 (n=399) |
|
| Month 4 (n=439) |
|
| Month 5 (n=366) |
|
| Month 6 (n=411) |
|
| Month 7 (n=443) |
|
| Month 8 (n=333) |
|
| Month 9 (n=323) |
|
| Month 10 (n=388) |
|
| Month 11 (n=307) |
|
| Month 12 (n=335) |
|
| Title | Measurements |
|---|---|
|
| Month 3 (n=375) |
|
| Month 4 (n=362) |
|
| Month 5 (n=323) |
|
| Month 6 (n=347) |
|
| Month 7 (n=362) |
|
| Month 8 (n=294) |
|
| Month 9 (n=284) |
|
| Month 10 (n=341) |
|
| Month 11 (n=263) |
|
| Month 12 (n=263) |
|
| Title | Measurements |
|---|---|
|
| Month 3 (n=274) |
|
| Month 4 (n=292) |
|
| Month 5 (n=231) |
|
| Month 6 (n=282) |
|
| Month 7 (n=287) |
|
| Month 8 (n=199) |
|
| Month 9 (n=205) |
|
| Month 10 (n=251) |
|
| Month 11 (n=175) |
|
| Month 12 (n=179) |
|
| Title | Measurements |
|---|---|
|
| Month 3 (n=282) |
|
| Month 4 (n=321) |
|
| Month 5 (n=276) |
|
| Month 6 (n=320) |
|
| Month 7 (n=316) |
|
| Month 8 (n=254) |
|
| Month 9 (n=241) |
|
| Month 10 (n=294) |
|
| Month 11 (n=227) |
|
| Month 12 (n=220) |
|
| Title | Measurements |
|---|---|
|
| Month 3 (n=589) |
|
| Month 4 (n=677) |
|
| Month 5 (n=552) |
|
| Month 6 (n=567) |
|
| Month 7 (n=623) |
|
| Month 8 (n=471) |
|
| Month 9 (n=514) |
|
| Month 10 (n=535) |
|
| Month 11 (n=478) |
|
| Month 12 (n=488) |
|
| Title | Measurements |
|---|---|
|
| Not satisfied |
|
| Missing |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Adverse event |
|
| Missing |
|
| Death |
|
| Methoxy polyethylene glycol-epoetin not available |
|
| Organizational reasons |
|
| Hospitalization/change of medical center |
|
| Transplantation |
|
| Treatment interruption/ESA currently not necessary |
|
| High hemoglobin levels |
|
| Relocation/vacation of participant |
|
| Lost to follow-up |
|
| Dialysis |
|
| Unknown |
|
| Change of therapy |
|
| Participant does not want to continue dialysis |
|
| Therapy withdrawal |
|
| Therapy omission |
|
| Title | Measurements |
|---|
|
| Erypo |
|
| NeoRecormon |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Not satisfied |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Month 3 (n=1234) |
|
| Month 4 (n=1192) |
|
| Month 5 (n=1157) |
|
| Month 6 (n=1115) |
|
| Month 7 (n=1075) |
|
| Month 8 (n=1014) |
|
| Month 9 (n=993) |
|
| Month 10 (n=954) |
|
| Month 11 (n=917) |
|
| Month 12 (n=907) |
|