Trial Outcomes & Findings for An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia (NCT NCT01051323)
NCT ID: NCT01051323
Last Updated: 2015-12-18
Results Overview
Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (\<) 10 g/dL or greater than (\>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
Recruitment status
COMPLETED
Target enrollment
1580 participants
Primary outcome timeframe
Month 0 to Month 12
Results posted on
2015-12-18
Participant Flow
Data of this non-interventional study were analyzed by the following strata: predialysis participants versus hemodialysis participants, unless otherwise specified.
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Overall Study
STARTED
|
1580
|
|
Overall Study
Received at Least One Dose
|
1547
|
|
Overall Study
COMPLETED
|
1041
|
|
Overall Study
NOT COMPLETED
|
539
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Overall Study
Discontinuation of treatment
|
103
|
|
Overall Study
Transplantation
|
28
|
|
Overall Study
Dialysis dependency
|
22
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Lost to Follow-up
|
31
|
|
Overall Study
Death
|
129
|
|
Overall Study
Hospitalization
|
28
|
|
Overall Study
Other
|
148
|
|
Overall Study
Missing
|
37
|
Baseline Characteristics
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=326 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
n=1184 Participants
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Total
n=1510 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
479 Participants
n=7 Participants
|
637 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=5 Participants
|
705 Participants
n=7 Participants
|
873 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 0 to Month 12Population: FAS
Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (\<) 10 g/dL or greater than (\>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=326 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
n=1184 Participants
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Hemoglobin value <10 g/dL
|
97.9 percentage of participants
|
72.9 percentage of participants
|
|
Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Hemoglobin value >13 g/dL
|
33.7 percentage of participants
|
35.3 percentage of participants
|
PRIMARY outcome
Timeframe: Month 0 to Month 12Population: FAS. n = participants evaluable for specified category for each arm group, respectively.
The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (\<65 years, greater than or equal to \[\>=\] 65 years) and center size (\>100 participants, less than or equal to \[\<=\] 100 participants) is presented.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=326 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
n=1184 Participants
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Center size >100: Hb 10-12 g/dL (n=99, 563)
|
17.2 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Center size >100: Hb 11-12 g/dL (n=99, 563)
|
2.0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Center size >100: Hb 11-13 g/dL (n=99, 563)
|
13.1 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Center size <=100: Hb 10-12 g/dL (n=227, 621)
|
5.3 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Center size <=100: Hb 11-12 g/dL (n=227, 621)
|
0 percentage of participants
|
0.2 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Center size <=100: Hb 11-13 g/dL (n=227, 621)
|
8.8 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
No dose modifications: Hb 10-12 g/dL (n=157, 242)
|
11.5 percentage of participants
|
8.7 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
No dose modifications: Hb 11-12 g/dL (n=157, 242)
|
0.6 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
No dose modifications: Hb 11-13 g/dL (n=157, 242)
|
11.5 percentage of participants
|
11.2 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
With dose modifications: Hb 10-12g/dL (n=169, 942)
|
6.5 percentage of participants
|
4.9 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
With dose modifications: Hb 11-12g/dL (n=169, 942)
|
0.6 percentage of participants
|
0.1 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
With dose modifications: Hb 11-13g/dL (n=169, 942)
|
8.9 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Age <65 years: Hb 10-12 g/dL (n=70, 402)
|
10.0 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Age <65 years: Hb 11-12 g/dL (n=70, 402)
|
1.4 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Age <65 years: Hb 11-13 g/dL (n=70, 402)
|
8.6 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Age >=65 years: Hb 10-12 g/dL (n=256, 782)
|
8.6 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Age >=65 years: Hb 11-12 g/dL (n=256, 782)
|
0.4 percentage of participants
|
0.1 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Age >=65 years: Hb 11-13 g/dL (n=256, 782)
|
10.5 percentage of participants
|
5.4 percentage of participants
|
PRIMARY outcome
Timeframe: Month 6 to Month 12Population: FAS. n = participants evaluable for specified category for each arm group, respectively.
The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (\<65 years, \>=65 years) and center size (\>100 participants, \<=100 participants) is presented.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=326 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
n=1184 Participants
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
With dose modifications: Hb 10-12g/dL (n=169, 942)
|
10.7 percentage of participants
|
14.6 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
With dose modifications: Hb 11-12g/dL (n=169, 942)
|
1.2 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
No dose modifications: Hb 10-12 g/dL (n=157, 242)
|
9.6 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
No dose modifications: Hb 11-12 g/dL (n=157, 242)
|
3.2 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
No dose modifications: Hb 11-13 g/dL (n=157, 242)
|
8.3 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
With dose modifications: Hb 11-13g/dL (n=169, 942)
|
9.5 percentage of participants
|
15.1 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Age <65 years: Hb 10-12 g/dL (n=70, 402)
|
11.4 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Age <65 years: Hb 11-12 g/dL (n=70, 402)
|
4.3 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Age <65 years: Hb 11-13 g/dL (n=70, 402)
|
12.9 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Age >=65 years: Hb 10-12 g/dL (n=256, 782)
|
9.8 percentage of participants
|
14.1 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Age >=65 years: Hb 11-12 g/dL (n=256, 782)
|
1.6 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Age >=65 years: Hb 11-13 g/dL (n=256, 782)
|
7.8 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Center size >100: Hb 10-12 g/dL (n=99, 563)
|
20.2 percentage of participants
|
14.9 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Center size >100: Hb 11-12 g/dL (n=99, 563)
|
7.1 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Center size >100: Hb 11-13 g/dL (n=99, 563)
|
15.2 percentage of participants
|
15.1 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Center size <=100: Hb 10-12 g/dL (n=227, 621)
|
5.7 percentage of participants
|
13.7 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Center size <=100: Hb 11-12 g/dL (n=227, 621)
|
0 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Center size <=100: Hb 11-13 g/dL (n=227, 621)
|
6.2 percentage of participants
|
14.2 percentage of participants
|
PRIMARY outcome
Timeframe: Month 0 to Month 12Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category.
For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (\<65 years, \>=65 years), and center size (\>100 participants, \<=100 participants) is presented. Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=1489 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Predialysis (n=317)
|
1.3 g/dL
Standard Deviation 0.8
|
—
|
|
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Hemodialysis (n=1172)
|
1.6 g/dL
Standard Deviation 0.8
|
—
|
|
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Age <65 years (n=467)
|
1.6 g/dL
Standard Deviation 0.8
|
—
|
|
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Age >=65 years (n=1022)
|
1.5 g/dL
Standard Deviation 0.8
|
—
|
|
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Center size >100 participants (n=654)
|
1.5 g/dL
Standard Deviation 0.8
|
—
|
|
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Center size <=100 participants (n=835)
|
1.6 g/dL
Standard Deviation 0.8
|
—
|
PRIMARY outcome
Timeframe: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint.
Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=807 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Serum Ferritin Values
Month 0 (n=807)
|
402.5 ng/mL
Standard Deviation 365.3
|
—
|
|
Serum Ferritin Values
Month 1 (n=509)
|
526.5 ng/mL
Standard Deviation 453.1
|
—
|
|
Serum Ferritin Values
Month 2 (n=420)
|
479.9 ng/mL
Standard Deviation 451.5
|
—
|
|
Serum Ferritin Values
Month 3 (n=399)
|
412.6 ng/mL
Standard Deviation 349.3
|
—
|
|
Serum Ferritin Values
Month 4 (n=439)
|
517.4 ng/mL
Standard Deviation 423.0
|
—
|
|
Serum Ferritin Values
Month 5 (n=366)
|
518.2 ng/mL
Standard Deviation 424.5
|
—
|
|
Serum Ferritin Values
Month 6 (n=411)
|
462.0 ng/mL
Standard Deviation 403.9
|
—
|
|
Serum Ferritin Values
Month 7 (n=443)
|
567.1 ng/mL
Standard Deviation 514.5
|
—
|
|
Serum Ferritin Values
Month 8 (n=333)
|
488.4 ng/mL
Standard Deviation 414.5
|
—
|
|
Serum Ferritin Values
Month 9 (n=323)
|
493.0 ng/mL
Standard Deviation 414.8
|
—
|
|
Serum Ferritin Values
Month 10 (n=388)
|
554.8 ng/mL
Standard Deviation 431.0
|
—
|
|
Serum Ferritin Values
Month 11 (n=307)
|
542.3 ng/mL
Standard Deviation 416.2
|
—
|
|
Serum Ferritin Values
Month 12 (n=335)
|
478.6 ng/mL
Standard Deviation 354.0
|
—
|
PRIMARY outcome
Timeframe: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint.
Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=644 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Serum Iron Values
Month 0 (n=644)
|
73.3 mcg/dL
Standard Deviation 65.9
|
—
|
|
Serum Iron Values
Month 1 (n=339)
|
69.5 mcg/dL
Standard Deviation 33.4
|
—
|
|
Serum Iron Values
Month 2 (n=351)
|
68.8 mcg/dL
Standard Deviation 37.1
|
—
|
|
Serum Iron Values
Month 3 (n=375)
|
74.5 mcg/dL
Standard Deviation 74.4
|
—
|
|
Serum Iron Values
Month 4 (n=362)
|
67.7 mcg/dL
Standard Deviation 31.2
|
—
|
|
Serum Iron Values
Month 5 (n=323)
|
68.9 mcg/dL
Standard Deviation 31.0
|
—
|
|
Serum Iron Values
Month 6 (n=347)
|
72.1 mcg/dL
Standard Deviation 32.7
|
—
|
|
Serum Iron Values
Month 7 (n=362)
|
74.4 mcg/dL
Standard Deviation 34.2
|
—
|
|
Serum Iron Values
Month 8 (n=294)
|
67.0 mcg/dL
Standard Deviation 31.9
|
—
|
|
Serum Iron Values
Month 9 (n=284)
|
74.3 mcg/dL
Standard Deviation 50.1
|
—
|
|
Serum Iron Values
Month 10 (n=341)
|
69.0 mcg/dL
Standard Deviation 29.2
|
—
|
|
Serum Iron Values
Month 11 (n=263)
|
64.8 mcg/dL
Standard Deviation 28.8
|
—
|
|
Serum Iron Values
Month 12 (n=263)
|
70.2 mcg/dL
Standard Deviation 29.7
|
—
|
PRIMARY outcome
Timeframe: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint.
Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=544 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Transferrin Values
Month 0 (n=544)
|
196.1 mg/dL
Standard Deviation 46.8
|
—
|
|
Transferrin Values
Month 1 (n=266)
|
187.9 mg/dL
Standard Deviation 40.4
|
—
|
|
Transferrin Values
Month 2 (n=271)
|
192.5 mg/dL
Standard Deviation 43.1
|
—
|
|
Transferrin Values
Month 3 (n=274)
|
192.6 mg/dL
Standard Deviation 44.2
|
—
|
|
Transferrin Values
Month 4 (n=292)
|
187.7 mg/dL
Standard Deviation 43.6
|
—
|
|
Transferrin Values
Month 5 (n=231)
|
193.6 mg/dL
Standard Deviation 41.9
|
—
|
|
Transferrin Values
Month 6 (n=282)
|
193.9 mg/dL
Standard Deviation 47.0
|
—
|
|
Transferrin Values
Month 7 (n=287)
|
188.4 mg/dL
Standard Deviation 44.0
|
—
|
|
Transferrin Values
Month 8 (n=199)
|
192.0 mg/dL
Standard Deviation 43.2
|
—
|
|
Transferrin Values
Month 9 (n=205)
|
188.1 mg/dL
Standard Deviation 44.7
|
—
|
|
Transferrin Values
Month 10 (n=251)
|
182.3 mg/dL
Standard Deviation 39.5
|
—
|
|
Transferrin Values
Month 11 (n=175)
|
186.9 mg/dL
Standard Deviation 45.1
|
—
|
|
Transferrin Values
Month 12 (n=179)
|
189.9 mg/dL
Standard Deviation 46.1
|
—
|
PRIMARY outcome
Timeframe: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint.
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=489 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Transferrin Saturation Values
Month 0 (n=489)
|
24.4 percent transferrin saturation
Standard Deviation 11.8
|
—
|
|
Transferrin Saturation Values
Month 1 (n=298)
|
27.3 percent transferrin saturation
Standard Deviation 15.2
|
—
|
|
Transferrin Saturation Values
Month 2 (n=308)
|
26.7 percent transferrin saturation
Standard Deviation 13.8
|
—
|
|
Transferrin Saturation Values
Month 3 (n=282)
|
28.0 percent transferrin saturation
Standard Deviation 13.8
|
—
|
|
Transferrin Saturation Values
Month 4 (n=321)
|
26.4 percent transferrin saturation
Standard Deviation 12.9
|
—
|
|
Transferrin Saturation Values
Month 5 (n=276)
|
27.5 percent transferrin saturation
Standard Deviation 14.1
|
—
|
|
Transferrin Saturation Values
Month 6 (n=320)
|
27.2 percent transferrin saturation
Standard Deviation 13.6
|
—
|
|
Transferrin Saturation Values
Month 7 (n=316)
|
28.2 percent transferrin saturation
Standard Deviation 13.8
|
—
|
|
Transferrin Saturation Values
Month 8 (n=254)
|
26.8 percent transferrin saturation
Standard Deviation 14.0
|
—
|
|
Transferrin Saturation Values
Month 9 (n=241)
|
27.4 percent transferrin saturation
Standard Deviation 12.3
|
—
|
|
Transferrin Saturation Values
Month 10 (n=294)
|
27.3 percent transferrin saturation
Standard Deviation 12.5
|
—
|
|
Transferrin Saturation Values
Month 11 (n=227)
|
25.7 percent transferrin saturation
Standard Deviation 12.1
|
—
|
|
Transferrin Saturation Values
Month 12 (n=220)
|
27.0 percent transferrin saturation
Standard Deviation 11.8
|
—
|
PRIMARY outcome
Timeframe: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=916 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
C-reactive Protein (CRP) Values
Month 0 (n=916)
|
13.3 mg/dL
Standard Deviation 28.5
|
—
|
|
C-reactive Protein (CRP) Values
Month 1 (n=641)
|
15.0 mg/dL
Standard Deviation 30.7
|
—
|
|
C-reactive Protein (CRP) Values
Month 2 (n=529)
|
12.9 mg/dL
Standard Deviation 24.1
|
—
|
|
C-reactive Protein (CRP) Values
Month 3 (n=589)
|
21.6 mg/dL
Standard Deviation 119.2
|
—
|
|
C-reactive Protein (CRP) Values
Month 4 (n=677)
|
14.5 mg/dL
Standard Deviation 74.8
|
—
|
|
C-reactive Protein (CRP) Values
Month 5 (n=552)
|
12.1 mg/dL
Standard Deviation 20.6
|
—
|
|
C-reactive Protein (CRP) Values
Month 6 (n=567)
|
15.0 mg/dL
Standard Deviation 35.8
|
—
|
|
C-reactive Protein (CRP) Values
Month 7 (n=623)
|
11.4 mg/dL
Standard Deviation 19.0
|
—
|
|
C-reactive Protein (CRP) Values
Month 8 (n=471)
|
16.5 mg/dL
Standard Deviation 66.0
|
—
|
|
C-reactive Protein (CRP) Values
Month 9 (n=514)
|
12.4 mg/dL
Standard Deviation 22.0
|
—
|
|
C-reactive Protein (CRP) Values
Month 10 (n=535)
|
11.1 mg/dL
Standard Deviation 18.2
|
—
|
|
C-reactive Protein (CRP) Values
Month 11 (n=478)
|
13.0 mg/dL
Standard Deviation 29.6
|
—
|
|
C-reactive Protein (CRP) Values
Month 12 (n=488)
|
11.2 mg/dL
Standard Deviation 23.4
|
—
|
PRIMARY outcome
Timeframe: Month 12 or early discontinuationPopulation: FAS
Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=1510 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Number of Physicians Satisfied With Treatment at Final Visit
Very satisfied
|
685 physicians
|
—
|
|
Number of Physicians Satisfied With Treatment at Final Visit
Satisfied
|
602 physicians
|
—
|
|
Number of Physicians Satisfied With Treatment at Final Visit
Undecided
|
136 physicians
|
—
|
|
Number of Physicians Satisfied With Treatment at Final Visit
Not satisfied
|
31 physicians
|
—
|
|
Number of Physicians Satisfied With Treatment at Final Visit
Missing
|
56 physicians
|
—
|
PRIMARY outcome
Timeframe: Month 12 or early discontinuationPopulation: FAS
At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=1510 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
Yes
|
944 participants
|
—
|
|
Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
No
|
490 participants
|
—
|
|
Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
Missing
|
76 participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 or early discontinuationPopulation: FAS. N (number of participants analyzed) = participants evaluable for this measure.
At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=490 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Participant's decision
|
24 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Physician's decision
|
177 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Insufficient efficacy
|
1 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Adverse event
|
5 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Missing
|
10 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Death
|
116 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Methoxy polyethylene glycol-epoetin not available
|
57 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Organizational reasons
|
34 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Hospitalization/change of medical center
|
19 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Transplantation
|
18 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Treatment interruption/ESA currently not necessary
|
14 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
High hemoglobin levels
|
10 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Relocation/vacation of participant
|
6 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Lost to follow-up
|
6 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Dialysis
|
5 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Unknown
|
5 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Change of therapy
|
4 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Participant does not want to continue dialysis
|
1 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Therapy withdrawal
|
1 participants
|
—
|
|
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Therapy omission
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 or early discontinuationPopulation: FAS. N (number of participants analyzed) = participants evaluable for this measure.
Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=169 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Aranesp
|
30 participants
|
—
|
|
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Biopoin
|
1 participants
|
—
|
|
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Biosimilar
|
21 participants
|
—
|
|
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Erypo
|
50 participants
|
—
|
|
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
NeoRecormon
|
46 participants
|
—
|
|
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Missing
|
21 participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 or early discontinuationPopulation: FAS
Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=1510 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Number of Participants Satisfied With Treatment at Final Visit
Very satisfied
|
593 participants
|
—
|
|
Number of Participants Satisfied With Treatment at Final Visit
Satisfied
|
713 participants
|
—
|
|
Number of Participants Satisfied With Treatment at Final Visit
Undecided
|
114 participants
|
—
|
|
Number of Participants Satisfied With Treatment at Final Visit
Not satisfied
|
16 participants
|
—
|
|
Number of Participants Satisfied With Treatment at Final Visit
Missing
|
74 participants
|
—
|
SECONDARY outcome
Timeframe: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during each timepoint.
Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=1485 Participants
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 0 (n=1485)
|
109.1 mcg
Standard Deviation 75.9
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 1 (n=1336)
|
121.8 mcg
Standard Deviation 102.2
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 2 (n=1292)
|
124.6 mcg
Standard Deviation 96.7
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 3 (n=1234)
|
126.2 mcg
Standard Deviation 94.1
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 4 (n=1192)
|
129.4 mcg
Standard Deviation 99.8
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 5 (n=1157)
|
130.5 mcg
Standard Deviation 110.2
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 6 (n=1115)
|
128.3 mcg
Standard Deviation 101.7
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 7 (n=1075)
|
129.3 mcg
Standard Deviation 105.1
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 8 (n=1014)
|
125.7 mcg
Standard Deviation 101.9
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 9 (n=993)
|
122.9 mcg
Standard Deviation 98.2
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 10 (n=954)
|
124.3 mcg
Standard Deviation 101.7
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 11 (n=917)
|
124.5 mcg
Standard Deviation 106.3
|
—
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 12 (n=907)
|
121.1 mcg
Standard Deviation 99.1
|
—
|
Adverse Events
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Serious events: 67 serious events
Other events: 196 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=346 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
n=1201 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.25%
3/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.17%
2/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.17%
2/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.58%
7/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
General disorders
Death
|
0.29%
1/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.42%
5/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
General disorders
General physical health deterioration
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
General disorders
Multi-organ failure
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Device related infection
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Infection
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.25%
3/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.25%
3/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Sepsis
|
0.29%
1/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.33%
4/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Investigations
Haemoglobin decreased
|
1.2%
4/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
1.3%
16/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Investigations
Platelet count decreased
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Surgical and medical procedures
Amputation
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Surgical and medical procedures
Arteriovenous shunt operation
|
0.29%
1/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.00%
0/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
0.08%
1/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
Other adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)
n=346 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
n=1201 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|---|
|
Investigations
Haemoglobin decreased
|
3.8%
13/346 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
16.3%
196/1201 • Month 0 to Month 12
Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
|
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