Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000126-46 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Experimental | Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Drug | Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL) | Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned. | Evaluation phase (Months 8 and 9) |
| Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL | Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned. | Evaluation phase (Months 8 and 9) |
| Change From Baseline in Hemoglobin Value to the Evaluation Phase | The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean. | Baseline, evaluation phase (Months 8 and 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hemoglobin Values in the Range of 11-12 g/dL | The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range. | Baseline to Month 9 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ansbach | 91522 | Germany | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-epoetin Beta | Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 micrograms per kilogram (mcg/kg) of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Duration of Hemoglobin Values in the Range of 11-13 g/dL | The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range. | Baseline to Month 9 |
| Time to Increase of Hemoglobin Value to Over 11 g/dL | The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL. | Baseline to Month 9 |
| Total Number of Dose Adjustments | A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment. | Baseline until Month 8 |
| Total Number of Red Blood Cell (RBC) Transfusions | RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels). | Baseline to Month 9 |
| Arnsberg |
| 59759 |
| Germany |
| Bad Aibling | 83043 | Germany |
| Berlin | 10115 | Germany |
| Bischofswerda | 01877 | Germany |
| Bonn | 53179 | Germany |
| Cologne | 50937 | Germany |
| Cologne | 51109 | Germany |
| Dieburg | 64807 | Germany |
| Dortmund | 44135 | Germany |
| Düsseldorf | 40211 | Germany |
| Emsdetten | 48282 | Germany |
| Frankfurt | 60528 | Germany |
| Friedberg | 86316 | Germany |
| Grimma | 04668 | Germany |
| Hamburg | 21073 | Germany |
| Hamburg | 22391 | Germany |
| Heidelberg | 69120 | Germany |
| Hilden | 40721 | Germany |
| Homburg | 66424 | Germany |
| Hoyerswerda | 02977 | Germany |
| Jena | 07743 | Germany |
| Kaiserslautern | 67655 | Germany |
| Loerrach | 79539 | Germany |
| Ludwigslust | 19288 | Germany |
| Lübeck | 23562 | Germany |
| Lünen | 44534 | Germany |
| Mainz | 55131 | Germany |
| Malente | 23714 | Germany |
| Mettmann | 40822 | Germany |
| Mühlacker | 75417 | Germany |
| München | 81545 | Germany |
| Regensburg | 93053 | Germany |
| Rheine | 48431 | Germany |
| Saarlouis | 66740 | Germany |
| Schwandorf in Bayern | 92421 | Germany |
| Schweinfurt | 97421 | Germany |
| Sindelfingen | 71063 | Germany |
| Sinsheim | 74889 | Germany |
| Tangermünde | 39590 | Germany |
| Trier | 54290 | Germany |
| Tübingen | 72076 | Germany |
| Ulm | 89077 | Germany |
| Velbert | 42549 | Germany |
| Wetzlar | 35578 | Germany |
| Wiesloch | 69168 | Germany |
| Worms | 67547 | Germany |
| Würzburg | 97072 | Germany |
| Würzburg | 97080 | Germany |
| Zwickau | 08056 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-epoetin Beta | Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis. |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL) | Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned. | Intent to treat (ITT) population included all participants who received at least one dose of study medication with at least one hemoglobin value measured during treatment period. | Posted | Number | 95% Confidence Interval | percentage of participants | Evaluation phase (Months 8 and 9) |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL | Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Evaluation phase (Months 8 and 9) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Hemoglobin Values in the Range of 11-12 g/dL | The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range. | ITT population | Posted | Mean | Standard Deviation | months | Baseline to Month 9 |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Hemoglobin Value to the Evaluation Phase | The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean. | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Mean | Standard Deviation | g/dL | Baseline, evaluation phase (Months 8 and 9) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Hemoglobin Values in the Range of 11-13 g/dL | The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range. | ITT population | Posted | Mean | Standard Deviation | months | Baseline to Month 9 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Increase of Hemoglobin Value to Over 11 g/dL | The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL. | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Mean | Standard Deviation | months | Baseline to Month 9 |
|
| ||||||||||||||||||||||||||
| Secondary | Total Number of Dose Adjustments | A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment. | ITT population | Posted | Number | dose adjustments | Baseline until Month 8 |
|
| |||||||||||||||||||||||||||
| Secondary | Total Number of Red Blood Cell (RBC) Transfusions | RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels). | ITT population | Posted | Number | number of transfusions | Baseline to Month 9 |
|
|
Baseline to Month 11
Safety population
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 | Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis. | 88 | 184 | 109 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Meningitis enterococcal | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diverticulitis intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
Not provided
Not provided
Not provided
|
|
|
|
|
|
|