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This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO0503821 (C.E.R.A.), 1x/4weeks | Experimental | Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | 120, 200 or 360 micrograms iv monthly (starting dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP | All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24 | EEP (Week 16 to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hb Concentration From Baseline to the EEP | A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kemerovo | 650066 | Russia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26965694 | Derived | Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10. |
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Of the 241 screened participants, 200 participants received the study drug and 41 participants were early withdrawals during the stability verification period (SVP)
A total of 241 participants were recruited across 19 centers in Russia. The study was conducted from 29 Apr 2008 to 09 Jun 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | RO0503821 (1x/4 Weeks) | Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the erythropoiesis stimulating agents (ESA) like epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Titration Period |
|
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| Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24) |
| Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP | All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24 | EEP (Week 16 to Week 24) |
| Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP | The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24 | EEP (Week 16 to Week 24) |
| Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP | The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44 | DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44) |
| Number of Participants With Red Blood Cell Transfusion | The number of participants who underwent red blood cell transfusion was reported | Up to 3 years |
| Krasnodar |
| 350086 |
| Russia |
| Moscow | 117049 | Russia |
| Moscow | 123182 | Russia |
| Moscow | 125101 | Russia |
| Moscow | 127006 | Russia |
| Moscow | 129110 | Russia |
| Moscow | 129317 | Russia |
| Novosibirsk | 630087 | Russia |
| Omsk | 644111 | Russia |
| Saint Petersburg | 191015 | Russia |
| Saint Petersburg | 195067 | Russia |
| Saint Petersburg | 196247 | Russia |
| Saint Petersburg | 197089 | Russia |
| Saint Petersburg | 197110 | Russia |
| Saint Petersburg | 198510 | Russia |
| Volzhsky | 404130 | Russia |
| Yekaterinburg | 620102 | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Efficacy Evaluation Period |
|
|
| Long Term Safety Period |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RO0503821 (1x/4 Weeks) | Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks |
| 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 Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP | All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24 | Per protocol (PP) population included participants except who didn't meet inclusion criterion relative to consent, stable baseline Hb values, iron status, epoetin maintenance, and who met exclusion criterion of hemoglobinopathies/hemolysis, bleeding, >3 recorded Hb, missing drug administration, other ESA, blood transfusion during the DTP or EEP. | Posted | Number | 95% Confidence Interval | percentage of participants | EEP (Week 16 to Week 24) |
|
|
| |||||||||||||||||||||||||
| Secondary | Mean Change in Hb Concentration From Baseline to the EEP | A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24 | The Intent-to-Treat (ITT) population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. | Posted | Mean | Standard Deviation | g/dL | Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP | All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24 | The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. | Posted | Number | 95% Confidence Interval | percentage of participants | EEP (Week 16 to Week 24) |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP | The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24 | The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. Of the 199 participants, analysis was conducted on 184 participants, as 15 participants did not maintain their hemoglobin, within range of 10.5-12.5 g/dL during the EEP. | Posted | Mean | Standard Deviation | number of days | EEP (Week 16 to Week 24) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP | The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44 | The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. . Data for the participants present at the time of assessment was used for analysis i.e. for DTP- 199, EEP-183, LTSP-178 respectively. | Posted | Number | number of participants | DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Red Blood Cell Transfusion | The number of participants who underwent red blood cell transfusion was reported | The safety population was defined as all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. | Posted | Number | number of participants | Up to 3 years |
|
|
Up to 3 years
Serious adverse events and non-serious adverse events are reported in the safety population.
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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 | RO0503821 (1x/4 Weeks) | Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks | 45 | 200 | 78 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyonephrosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Renal cyst infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Peritoneal dialysis complication | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetic coma | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Retinopathy hypertensive | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrooesophageal sphincter insufficiency | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyonephrosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Viral hepatitis carrier | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriovenous fistula site haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Poisoning | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Radiculitis cervical | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Radiculitis lumbosacral | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA 13.1 | 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 | |
|---|---|---|---|---|
| Name/Official Title:Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.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
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