Trial Outcomes & Findings for Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine (NCT NCT01309269)
NCT ID: NCT01309269
Last Updated: 2016-11-02
Results Overview
Hemoglobin levels were measured as grams/deciliter (g/dL).
Recruitment status
COMPLETED
Target enrollment
1083 participants
Primary outcome timeframe
Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Results posted on
2016-11-02
Participant Flow
In this non-interventional study, physician was completely free in his/her decision which participants he/she treated with the medication selected in this study, what dosage was chosen, which diagnostic measures were taken, how the course of treatment was monitored and what accompanying or supplemental medications were prescribed.
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Overall Study
STARTED
|
1085
|
|
Overall Study
Treated
|
978
|
|
Overall Study
COMPLETED
|
245
|
|
Overall Study
NOT COMPLETED
|
840
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Overall Study
Adverse Event
|
56
|
|
Overall Study
Withdrawal by Subject
|
25
|
|
Overall Study
Lack of Acceptance
|
15
|
|
Overall Study
Other Erythropoiesis-stimulating Agents
|
119
|
|
Overall Study
Kidney Transplant
|
25
|
|
Overall Study
Administrative Problems
|
141
|
|
Overall Study
Other
|
1
|
|
Overall Study
Study Completion Data Not Recorded
|
95
|
|
Overall Study
Enrolled but not Treated
|
107
|
Baseline Characteristics
Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=978 Participants
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Gender
Female
|
428 Participants
n=5 Participants
|
|
Gender
Male
|
550 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24Population: Effectiveness Population I: all participants for whom at least 1 hemoglobin value was documented after the first application of methoxy polyethylene glycol-epoetin beta during the study course. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.
Hemoglobin levels were measured as grams/deciliter (g/dL).
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=926 Participants
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Hemoglobin Levels at Monthly Intervals
Prior to Day 1 (n=926)
|
11.15 g/dL
Standard Deviation 1.21
|
|
Hemoglobin Levels at Monthly Intervals
Month 1 (Day 1-45) (n=802)
|
11.31 g/dL
Standard Deviation 1.24
|
|
Hemoglobin Levels at Monthly Intervals
Month 2 (Day 46-75) (n=715)
|
11.33 g/dL
Standard Deviation 1.23
|
|
Hemoglobin Levels at Monthly Intervals
Month 3 (Day 76-105) (n=684)
|
11.28 g/dL
Standard Deviation 1.32
|
|
Hemoglobin Levels at Monthly Intervals
Month 4 (Day 106-135) (n=685)
|
11.28 g/dL
Standard Deviation 1.25
|
|
Hemoglobin Levels at Monthly Intervals
Month 5 (Day 136-165) (n=602)
|
11.25 g/dL
Standard Deviation 1.22
|
|
Hemoglobin Levels at Monthly Intervals
Month 6 (Day 166-195) (n=580)
|
11.36 g/dL
Standard Deviation 1.27
|
|
Hemoglobin Levels at Monthly Intervals
Month 7 (Day 196-225) (n=541)
|
11.30 g/dL
Standard Deviation 1.26
|
|
Hemoglobin Levels at Monthly Intervals
Month 8 (Day 226-255) (n=516)
|
11.31 g/dL
Standard Deviation 1.25
|
|
Hemoglobin Levels at Monthly Intervals
Month 9 (Day 256-285) (n=436)
|
11.46 g/dL
Standard Deviation 1.28
|
|
Hemoglobin Levels at Monthly Intervals
Month 10 (Day 286-315) (n=423)
|
11.40 g/dL
Standard Deviation 1.27
|
|
Hemoglobin Levels at Monthly Intervals
Month 11 (Day 316-345) (n=402)
|
11.44 g/dL
Standard Deviation 1.31
|
|
Hemoglobin Levels at Monthly Intervals
Month 12 (Day 346-375) (n=374)
|
11.31 g/dL
Standard Deviation 1.27
|
|
Hemoglobin Levels at Monthly Intervals
Month 13 (Day 376-405) (n=351)
|
11.29 g/dL
Standard Deviation 1.16
|
|
Hemoglobin Levels at Monthly Intervals
Month 14 (Day 406-435) (n=344)
|
11.26 g/dL
Standard Deviation 1.16
|
|
Hemoglobin Levels at Monthly Intervals
Month 15 (Day 436-465) (n=304)
|
11.30 g/dL
Standard Deviation 1.20
|
|
Hemoglobin Levels at Monthly Intervals
Month 16 (Day 466-495) (n=272)
|
11.37 g/dL
Standard Deviation 1.19
|
|
Hemoglobin Levels at Monthly Intervals
Month 17 (Day 496-525) (n=265)
|
11.34 g/dL
Standard Deviation 1.27
|
|
Hemoglobin Levels at Monthly Intervals
Month 18 (Day 526-555) (n=226)
|
11.36 g/dL
Standard Deviation 1.13
|
|
Hemoglobin Levels at Monthly Intervals
Month 19 (Day 556-585) (n=213)
|
11.28 g/dL
Standard Deviation 1.22
|
|
Hemoglobin Levels at Monthly Intervals
Month 20 (Day 586-615) (n=187)
|
11.16 g/dL
Standard Deviation 1.16
|
|
Hemoglobin Levels at Monthly Intervals
Month 21 (Day 616-645) (n=186)
|
11.23 g/dL
Standard Deviation 1.16
|
|
Hemoglobin Levels at Monthly Intervals
Month 22 (Day 646-675) (n=167)
|
11.38 g/dL
Standard Deviation 1.21
|
|
Hemoglobin Levels at Monthly Intervals
Month 23 (Day 676-705) (n=143)
|
11.34 g/dL
Standard Deviation 1.13
|
|
Hemoglobin Levels at Monthly Intervals
Month 24 (Day 706-735) (n=37)
|
11.66 g/dL
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24Population: Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.
Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=802 Participants
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 2 (Day 46-75) (n=715)
|
81.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 11 (Day 316-345) (n=402)
|
80.6 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 12 (Day 346-375) (n=374)
|
36.6 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 12 (Day 346-375) (n=374)
|
54.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 12 (Day 346-375) (n=374)
|
78.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 13 (Day 376-405) (n=351)
|
37.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 1 (Day 1-45) (n=802)
|
37.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 1 (Day 1-45) (n=802)
|
61.6 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 1 (Day 1-45) (n=802)
|
56.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 1 (Day 1-45) (n=802)
|
80.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 2 (Day 46-75) (n=715)
|
39.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 2 (Day 46-75) (n=715)
|
62.2 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 2 (Day 46-75) (n=715)
|
58.2 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 3 (Day 76-105) (n=684)
|
33.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 3 (Day 76-105) (n=684)
|
58.3 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 3 (Day 76-105) (n=684)
|
53.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 3 (Day 76-105) (n=684)
|
77.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 4 (Day 106-135) (n=685)
|
35.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 4 (Day 106-135) (n=685)
|
62.6 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 4 (Day 106-135) (n=685)
|
53.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 4 (Day 106-135) (n=685)
|
81.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 5 (Day 136-165) (n=602)
|
36.2 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 5 (Day 136-165) (n=602)
|
65.3 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 5 (Day 136-165) (n=602)
|
53.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 5 (Day 136-165) (n=602)
|
82.6 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 6 (Day 166-195) (n=580)
|
41.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 6 (Day 166-195) (n=580)
|
64.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 6 (Day 166-195) (n=580)
|
57.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 6 (Day 166-195) (n=580)
|
80.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 7 (Day 196-225) (n=541)
|
39.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 7 (Day 196-225) (n=541)
|
62.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 7 (Day 196-225) (n=541)
|
56.6 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 7 (Day 196-225) (n=541)
|
80.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 8 (Day 226-255) (n=516)
|
37.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 8 (Day 226-255) (n=516)
|
60.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 8 (Day 226-255) (n=516)
|
56.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 8 (Day 226-255) (n=516)
|
79.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 9 (Day 256-285) (n=436)
|
38.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 9 (Day 256-285) (n=436)
|
58.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 9 (Day 256-285) (n=436)
|
58.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 9 (Day 256-285) (n=436)
|
78.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 10 (Day 286-315) (n=423)
|
39.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 10 (Day 286-315) (n=423)
|
60.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 10 (Day 286-315) (n=423)
|
59.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 20 (Day 586-615) (n=187)
|
36.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 20 (Day 586-615) (n=187)
|
62.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 20 (Day 586-615) (n=187)
|
54.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 20 (Day 586-615) (n=187)
|
79.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 21 (Day 616-645) (n=186)
|
37.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 21 (Day 616-645) (n=186)
|
63.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 21 (Day 616-645) (n=186)
|
55.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 21 (Day 616-645) (n=186)
|
81.7 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 22 (Day 646-675) (n=167)
|
47.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 22 (Day 646-675) (n=167)
|
68.3 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 22 (Day 646-675) (n=167)
|
63.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 22 (Day 646-675) (n=167)
|
83.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 23 (Day 676-705) (n=143)
|
30.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 23 (Day 676-705) (n=143)
|
61.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 23 (Day 676-705) (n=143)
|
54.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 23 (Day 676-705) (n=143)
|
85.3 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 10 (Day 286-315) (n=423)
|
80.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 11 (Day 316-345) (n=402)
|
38.3 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 11 (Day 316-345) (n=402)
|
61.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 11 (Day 316-345) (n=402)
|
57.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 12 (Day 346-375) (n=374)
|
60.7 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 13 (Day 376-405) (n=351)
|
63.2 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 13 (Day 376-405) (n=351)
|
57.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 13 (Day 376-405) (n=351)
|
82.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 14 (Day 406-435) (n=344)
|
35.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 14 (Day 406-435) (n=344)
|
64.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 14 (Day 406-435) (n=344)
|
54.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 14 (Day 406-435) (n=344)
|
83.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 15 (Day 436-465) (n=304)
|
36.2 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 15 (Day 436-465) (n=304)
|
64.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 15 (Day 436-465) (n=304)
|
54.3 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 15 (Day 436-465) (n=304)
|
82.2 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 16 (Day 466-495) (n=272)
|
34.9 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 16 (Day 466-495) (n=272)
|
64.0 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 16 (Day 466-495) (n=272)
|
54.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 16 (Day 466-495) (n=272)
|
83.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 17 (Day 496-525) (n=265)
|
35.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 17 (Day 496-525) (n=265)
|
64.2 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 17 (Day 496-525) (n=265)
|
52.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 17 (Day 496-525) (n=265)
|
80.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 18 (Day 526-555) (n=226)
|
41.6 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 18 (Day 526-555) (n=226)
|
67.3 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 18 (Day 526-555) (n=226)
|
57.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 18 (Day 526-555) (n=226)
|
83.2 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 19 (Day 556-585) (n=213)
|
37.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 19 (Day 556-585) (n=213)
|
62.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 19 (Day 556-585) (n=213)
|
54.5 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 19 (Day 556-585) (n=213)
|
79.8 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-12 g/dL: Month 24 (Day 706-735) (n=37)
|
35.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-12 g/dL: Month 24 (Day 706-735) (n=37)
|
54.1 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
11-13 g/dL: Month 24 (Day 706-735) (n=37)
|
51.4 percentage of participants
|
|
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
10-13 g/dL: Month 24 (Day 706-735) (n=37)
|
70.3 percentage of participants
|
PRIMARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24Population: Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during study period considered.
Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=933 Participants
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 1 (Day 1-45) (n=933)
|
103.23 microgram (mcg)
Standard Deviation 68.23
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 2 (Day 46-75) (n=797)
|
102.27 microgram (mcg)
Standard Deviation 70.96
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 3 (Day 76-105) (n=785)
|
102.48 microgram (mcg)
Standard Deviation 71.23
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 4 (Day 106-135) (n=758)
|
102.64 microgram (mcg)
Standard Deviation 70.88
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 5 (Day 136-165) (n=700)
|
104.55 microgram (mcg)
Standard Deviation 74.81
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 6 (Day 166-195) (n=673)
|
102.87 microgram (mcg)
Standard Deviation 76.01
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 7 (Day 196-225) (n=631)
|
101.08 microgram (mcg)
Standard Deviation 77.76
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 8 (Day 226-255) (n=562)
|
103.13 microgram (mcg)
Standard Deviation 77.41
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 9 (Day 256-285) (n=509)
|
103.31 microgram (mcg)
Standard Deviation 78.43
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 10 (Day 286-315) (n=481)
|
104.62 microgram (mcg)
Standard Deviation 77.59
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 11 (Day 316-345) (n=452)
|
103.37 microgram (mcg)
Standard Deviation 75.16
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 12 (Day 346-375) (n=396)
|
104.88 microgram (mcg)
Standard Deviation 77.43
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 13 (Day 376-405) (n=382)
|
103.63 microgram (mcg)
Standard Deviation 79.82
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 14 (Day 406-435) (n=375)
|
107.37 microgram (mcg)
Standard Deviation 81.52
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 15 (Day 436-465) (n=328)
|
105.49 microgram (mcg)
Standard Deviation 80.50
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 16 (Day 466-495) (n=290)
|
113.21 microgram (mcg)
Standard Deviation 82.47
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 17 (Day 496-525) (n=281)
|
107.10 microgram (mcg)
Standard Deviation 82.63
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 18 (Day 526-555) (n=262)
|
101.96 microgram (mcg)
Standard Deviation 81.36
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 19 (Day 556-585) (n=230)
|
107.25 microgram (mcg)
Standard Deviation 80.88
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 20 (Day 586-615) (n=196)
|
110.81 microgram (mcg)
Standard Deviation 87.95
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 21 (Day 616-645) (n=201)
|
107.80 microgram (mcg)
Standard Deviation 90.14
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 22 (Day 646-675) (n=166)
|
109.98 microgram (mcg)
Standard Deviation 88.88
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 23 (Day 676-705) (n=144)
|
118.49 microgram (mcg)
Standard Deviation 102.60
|
|
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Month 24 (Day 706-735) (n=46)
|
116.30 microgram (mcg)
Standard Deviation 88.00
|
Adverse Events
Methoxy Polyethylene Glycol-epoetin Beta
Serious events: 172 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=978 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Acute myocardial infarction
|
0.51%
5/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Angina pectoris
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Aortic valve stenosis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
6/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Atrial flutter
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Atrioventricular block
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Bradyarrhythmia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Bradycardia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Cardiac arrest
|
0.51%
5/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Cardiac disorder
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Cardiac failure
|
0.82%
8/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Cardiac tamponade
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Cardiogenic shock
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Cardiomegaly
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Coronary artery stenosis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Mitral valve incompetence
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Mitral valve stenosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
11/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Pericardial effusion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Ventricular tachycardia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Endocrine disorders
Hyperthyroidism
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Endocrine disorders
Hypopituitarism
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Eye disorders
Pupils unequal
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
0.51%
5/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Enteritis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Faecaloma
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal telangiectasia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Haematochezia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Melaena
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Asthenia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Chest pain
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Death
|
2.1%
21/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Device dislocation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Device malfunction
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Disease progression
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Gait disturbance
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
General physical health deterioration
|
0.61%
6/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Mucosal haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Multi-organ failure
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Pain
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Pyrexia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Sudden cardiac death
|
0.82%
8/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Systemic inflammatory response syndrome
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Hepatobiliary disorders
Liver disorder
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Abscess
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Brain abscess
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Bronchopneumonia
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Cytomegalovirus enteritis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Cytomegalovirus infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Enterobacter infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Erysipelas
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Gangrene
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Infection
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Lobar pneumonia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Otitis externa
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Perinephric abscess
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Peritonitis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
1.1%
11/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Pneumonia chlamydial
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Postoperative wound infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Pyelocystitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Pyonephrosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
0.82%
8/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Septic shock
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Shunt infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Staphylococcal infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Staphylococcal sepsis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Tracheobronchitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Vaginal infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Viral myocarditis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Concussion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Contusion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
0.92%
9/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Laceration
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Overdose
|
0.51%
5/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Seroma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Blood bicarbonate decreased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Blood lactic acid increased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Blood potassium increased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Blood pressure increased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
C-reactive protein increased
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Haemoglobin decreased
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Acidosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer recurrent
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Alcohol induced persisting dementia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Brain injury
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Cerebral amyloid angiopathy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Cerebral infarction
|
0.51%
5/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Convulsion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Depressed level of consciousness
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Grand mal convulsion
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Monoplegia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Speech disorder
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Status epilepticus
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Syncope
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Psychiatric disorders
Confusional state
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Azotaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Prerenal failure
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Renal failure
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Renal failure acute
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Renal failure chronic
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Renal impairment
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Fibrinous bronchitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Umbilical haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Social circumstances
Immobile
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Social circumstances
Treatment noncompliance
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Amputation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Arteriovenous shunt operation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Heart valve operation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Hospitalisation
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Hysterectomy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Leg amputation
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Thyroidectomy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Aortic stenosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Arteriosclerosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Arteriosclerosis moenckeberg-type
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Haemorrhage
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Hypertensive crisis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Hypotension
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.61%
6/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Peripheral artery stenosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Peripheral ischaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Vena cava thrombosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Hemiparesis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
Other adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=978 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Acute coronary syndrome
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Aortic valve incompetence
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Bradyarrhythmia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Cardiac failure
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Cardiac failure chronic
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Hypertensive heart disease
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Cardiac disorders
Palpitations
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Ear and labyrinth disorders
Vertigo
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Endocrine disorders
Hyperparathyroidism
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Endocrine disorders
Hypoparathyroidism
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Endocrine disorders
Hypothyroidism
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Endocrine disorders
Toxic nodular goitre
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Eye disorders
Blindness
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Eye disorders
Conjunctivitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Dry mouth
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Faecaloma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Flatulence
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Haematemesis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Ileus
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Oral discomfort
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Papilla of vater stenosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Asthenia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Chest discomfort
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Chest pain
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Drug ineffective
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Fatigue
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Gait disturbance
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
General physical health deterioration
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Necrosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Pain
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Pyrexia
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Thrombosis in device
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
General disorders
Unevaluable event
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Hepatobiliary disorders
Bile duct stone
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholestasis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Hepatobiliary disorders
Jaundice
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Bacterial disease carrier
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
0.51%
5/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Bronchitis bacterial
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Catheter site infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Colostomy infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Endocarditis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Febrile infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Gangrene
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Haematoma infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Infective myositis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Klebsiella infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Lung abscess
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Shunt infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.61%
6/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Infections and infestations
Wound infection staphylococcal
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Concussion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Laceration
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Overdose
|
0.61%
6/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Shunt aneurysm
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.51%
5/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Blood calcium abnormal
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Blood parathyroid hormone increased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
C-reactive protein increased
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Haemoglobin abnormal
|
0.61%
6/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Haemoglobin decreased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Haemoglobin increased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Neurological examination normal
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Volume blood decreased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Investigations
Weight decreased
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Gout
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
5/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Convulsion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Dementia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Facial paresis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Neuropathy peripheral
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Polyneuropathy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Restless legs syndrome
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Sensory disturbance
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Syncope
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Nervous system disorders
Tremor
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Psychiatric disorders
Initial insomnia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Psychiatric disorders
Middle insomnia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Psychiatric disorders
Sleep disorder
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Azotaemia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Renal failure
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Renal and urinary disorders
Urinary retention
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subepidermal
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Social circumstances
Dependence on enabling machine or device
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Aneurysm repair
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Angioplasty
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Arteriovenous shunt operation
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Cataract operation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Choledocholithotomy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Duodenal sphincterotomy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Haemodialysis
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Intra-aortic balloon placement
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Laser therapy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Leg amputation
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Packed red blood cell transfusion
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Radioactive iodine therapy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Skin lesion excision
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Thrombectomy
|
0.20%
2/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Thrombolysis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Surgical and medical procedures
Vasodilation procedure
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Haematoma
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
0.41%
4/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Hypertensive crisis
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Hypotension
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.31%
3/978 • Day 1 up to Month 24
Safety Analysis Set
|
|
Vascular disorders
Superior vena cava syndrome
|
0.10%
1/978 • Day 1 up to Month 24
Safety Analysis Set
|
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