Trial Outcomes & Findings for An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis (NCT NCT02238080)
NCT ID: NCT02238080
Last Updated: 2017-05-15
Results Overview
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Recruitment status
COMPLETED
Target enrollment
197 participants
Primary outcome timeframe
Day 1
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
Participants with anemia and chronic kidney disease (CKD) who were on dialysis therapy, and who initiated erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta (Mircera) or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
|
|---|---|
|
Overall Study
STARTED
|
197
|
|
Overall Study
COMPLETED
|
172
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
Participants with anemia and chronic kidney disease (CKD) who were on dialysis therapy, and who initiated erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta (Mircera) or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
|
|---|---|
|
Overall Study
Death
|
13
|
|
Overall Study
Treatment interrupted
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=197 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
|
|---|---|
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Age, Continuous
|
66.7 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=185 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
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|---|---|
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Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
|
0.1485 correlation coefficient
|
PRIMARY outcome
Timeframe: Day 1Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=185 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
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|---|---|
|
Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
|
0.05557 correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6Population: ITT population. Participants with stable maintenance treatment were included in this analysis.
Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than \[\>\] 200 micrograms per kilogram \[mcg/kg\]), and (c) Dose decrease (1 to \>200 mcg/kg).
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=189 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
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|---|---|
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Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
No change
|
46.5 percentage of participants
|
|
Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Dose increase
|
29.9 percentage of participants
|
|
Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Dose decrease
|
23.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. 'Number analyzed' included participants evaluable for individual categories.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=186 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
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|---|---|
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Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Baseline
|
175.2 mcg/kg
Standard Deviation 109.8
|
|
Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Change at Month 6
|
13.6 mcg/kg
Standard Deviation 100.6
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=189 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
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|---|---|
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Serum CRP Level
Baseline
|
13.7 milligrams per liter (mg/L)
Standard Deviation 18.7
|
|
Serum CRP Level
Month 6
|
16.3 milligrams per liter (mg/L)
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=189 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
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|---|---|
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Serum IL-6 Level
Baseline
|
15.8 picograms per milliliter (pg/mL)
Standard Deviation 13.5
|
|
Serum IL-6 Level
Month 6
|
16.7 picograms per milliliter (pg/mL)
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Month 6Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=155 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
|
|---|---|
|
Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
|
0.12684 correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=154 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
|
|---|---|
|
Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
|
0.19473 correlation coefficient
|
SECONDARY outcome
Timeframe: Day 1Population: As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Population: As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: ITT population. 'Number analyzed' included participants evaluable for individual categories.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=197 Participants
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
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|---|---|
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Serum Hemoglobin Level
Baseline
|
11.2 grams per deciliter (g/dL)
Standard Deviation 1.0
|
|
Serum Hemoglobin Level
Month 6
|
11.2 grams per deciliter (g/dL)
Standard Deviation 1.4
|
Adverse Events
Methoxy Polyethylene Glycol-Epoetin Beta
Serious events: 48 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=197 participants at risk
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
4/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
1.0%
2/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Gastrointestinal disorders
Peritonitis
|
1.5%
3/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
General disorders
Chest pain
|
1.5%
3/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
General disorders
Chills
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
General disorders
Death
|
1.5%
3/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
General disorders
Pyrexia
|
1.0%
2/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Bacteremia
|
1.0%
2/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Bacterial sepsis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Cellulitis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Device related sepsis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Gangrene
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Gastroenteritis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Localized infection
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Paronychia
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Peritonitis bacterial
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Pneumonia
|
3.0%
6/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Sepsis
|
1.5%
3/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Septic shock
|
2.5%
5/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Urosepsis
|
1.0%
2/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
2/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Nervous system disorders
Hemiplegia
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Nervous system disorders
Ischemic stroke
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Nervous system disorders
Syncope
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Nervous system disorders
Transient ischemic attack
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Surgical and medical procedures
Leg amputation
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Vascular disorders
Aortic stenosis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Vascular disorders
Femoral artery occlusion
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Vascular disorders
Microscopic polyangiitis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
Other adverse events
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=197 participants at risk
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
2/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Cardiac disorders
Extrasystoles
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
General disorders
Asthenia
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Breast cellulitis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Cellulitis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Infection
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Infections and infestations
Pneumonia
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Investigations
Venous pressure increased
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Nervous system disorders
Headache
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Surgical and medical procedures
Leg amputation
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Surgical and medical procedures
Toe amputation
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Vascular disorders
Arteriovenous fistula
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.51%
1/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
|
Vascular disorders
Hypertension
|
1.0%
2/197 • Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER