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This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Early Epoetin Beta) | Experimental | Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion. |
|
| Group 2 (No/Late Epoetin Beta) | Active Comparator | Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin beta | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 | LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 - (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2). | Baseline, Month 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular End Systolic Volume Index (LVESVI) | LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters [mL]) with body surface area (BSA) (in meter square [m^2]). LVESVI is presented in milliliter per meter square (mL/m^2). | Baseline, Months 6 and 15 |
| Left Ventricular End Diastolic Volume Index (LVEDVI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebenhard Ritz, Prof. Dr. | unaffliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linz | 4020 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. | |
| 17261422 | Derived | Ritz E, Laville M, Bilous RW, O'Donoghue D, Scherhag A, Burger U, de Alvaro F; Anemia Correction in Diabetes Study Investigators. Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study. Am J Kidney Dis. 2007 Feb;49(2):194-207. doi: 10.1053/j.ajkd.2006.11.032. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Early Epoetin Beta) | Along with their standard treatment participants received epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses were adjusted according to individual participant's Hb level. Standard treatment was as per investigator discretion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m^2). LVEDVI was presented in mL/m^2. |
| Baseline, Months 6 and 15 |
| Fractional Myocardial Shortening (FS) | FS was calculated as: ([LVEDD - LVESD] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters [cm]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV. | Baseline, Months 6 and 15 |
| Left Ventricular Ejection Fraction (LVEF) | LVEF was calculated as ([LVEDV - LVESV], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV. | Baseline, Months 6 and 15 |
| Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL | Week 26 up to Week 64 |
| São Paulo |
| 04038-002 |
| Brazil |
| Jihlava | 586 33 | Czechia |
| Liberec | 460 63 | Czechia |
| Copenhagen | 2100 | Denmark |
| Roskilde | 4000 | Denmark |
| Jyväskylä | 40620 | Finland |
| Heidelberg | 69115 | Germany |
| München | 81675 | Germany |
| Alexandroupoli | 68100 | Greece |
| Athens | 11526 | Greece |
| Ioannina | 45500 | Greece |
| Nikaia | 18354 | Greece |
| Thessaloniki | 546 36 | Greece |
| Thessaloniki | 54629 | Greece |
| Véria | 59100 | Greece |
| Budapest | 1076 | Hungary |
| Budapest | 1115 | Hungary |
| Miskolc | 3526 | Hungary |
| Pécs | 7624 | Hungary |
| Szombathely | 9700 | Hungary |
| Ancona | 60121 | Italy |
| Cagliari | 09100 | Italy |
| Caserta | 81100 | Italy |
| Cinisello Balsamo | 20092 | Italy |
| Desio | 20033 | Italy |
| Lecco | 23900 | Italy |
| Messina | 98122 | Italy |
| Milan | 20132 | Italy |
| Milan | 20162 | Italy |
| Chihuahua City | 31238 | Mexico |
| Mexico City | 14000 | Mexico |
| Monterrey | 64460 | Mexico |
| Bialystok | 15-540 | Poland |
| Katowice | 40-027 | Poland |
| Radom | 26 600 | Poland |
| Moscow | 109263 | Russia |
| Moscow | 117036 | Russia |
| Moscow | 123 448 | Russia |
| Moscow | 125315 | Russia |
| Singapore | 169608 | Singapore |
| A Coruña | 15006 | Spain |
| Barakaldo | 48903 | Spain |
| Barcelona | 08907 | Spain |
| Galdakao | 48960 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28046 | Spain |
| Valencia | 46017 | Spain |
| Stockholm | 118 83 | Sweden |
| Bangkok | 10220 | Thailand |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Chon Buri | 20000 | Thailand |
| Belfast | BT9 7LJ | United Kingdom |
| Cambridge | CB2 2QQ | United Kingdom |
| London | E1 1BB | United Kingdom |
| London | N18 1QX | United Kingdom |
| London | SE22 8PT | United Kingdom |
| Middlesbrough | TS4 3BW | United Kingdom |
| Salford | M6 8HD | United Kingdom |
| Sheffield | S57AU | United Kingdom |
| Wrexham | LL13 7TD | United Kingdom |
| FG001 | Group 2 (No/Late Epoetin Beta) | Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Early Epoetin Beta) | Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant's Hb level. Standard treatment was as per investigator discretion. |
| BG001 | Group 2 (No/Late Epoetin Beta) | Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 | LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 - (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2). | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/m^2 | Baseline, Month 15 |
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| Secondary | Left Ventricular End Systolic Volume Index (LVESVI) | LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters [mL]) with body surface area (BSA) (in meter square [m^2]). LVESVI is presented in milliliter per meter square (mL/m^2). | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category, for respective arm groups. | Posted | Mean | Standard Deviation | mL/m^2 | Baseline, Months 6 and 15 |
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| Secondary | Left Ventricular End Diastolic Volume Index (LVEDVI) | LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m^2). LVEDVI was presented in mL/m^2. | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category, for respective arm groups. | Posted | Mean | Standard Deviation | mL/m^2 | Baseline, Months 6 and 15 |
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| Secondary | Fractional Myocardial Shortening (FS) | FS was calculated as: ([LVEDD - LVESD] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters [cm]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV. | ITT population. Here "n"= participants who were evaluable for each category, for respective arm groups. | Posted | Mean | Standard Deviation | percentage of LVEDV | Baseline, Months 6 and 15 |
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| Secondary | Left Ventricular Ejection Fraction (LVEF) | LVEF was calculated as ([LVEDV - LVESV], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV. | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here "n"= participants who were evaluable for each category, for respective arm groups. | Posted | Mean | Standard Deviation | percentage of LVEDV | Baseline, Months 6 and 15 |
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| Secondary | Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 26 up to Week 64 |
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up to 30 days after last study drug administration (35 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (Early Epoetin Beta) | Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant's Hb level. Standard treatment was as per investigator discretion. | 21 | 88 | 21 | 88 | ||
| EG001 | Group 2 (No/Late Epoetin Beta) | Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion. | 20 | 82 | 17 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Impairment | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Renal failure chronic | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Diabetic gangrene | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Perianal abscess | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Atherosclerosis | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Vasculitis | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Eye hemorrhage | Eye disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Vitreous hemorrhage | Eye disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Generalized edema | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
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| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
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| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Cataract operation | Surgical and medical procedures | MedDRA (8.0) | Non-systematic Assessment |
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| Toe amputation | Surgical and medical procedures | MedDRA (8.0) | Non-systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Hypertensive encephalopathy | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Edema peripheral | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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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-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 |
|---|---|
| C103998 | epoetin beta |
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