Trial Outcomes & Findings for A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis. (NCT NCT00454246)
NCT ID: NCT00454246
Last Updated: 2011-12-16
Results Overview
Efficacy analyses were not performed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
6-7 months post initiation of dialysis
Results posted on
2011-12-16
Participant Flow
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Epoetin Alfa
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Darbepoetin Alfa
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
29
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
73
|
29
|
9
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Epoetin Alfa
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Darbepoetin Alfa
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
|
Overall Study
Violation of selection criteria at entry
|
6
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Refused Treatment
|
1
|
1
|
0
|
|
Overall Study
Failure to return
|
1
|
0
|
0
|
|
Overall Study
Early termination of study
|
62
|
26
|
9
|
Baseline Characteristics
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=69 Participants
120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Epoetin Alfa
n=26 Participants
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Darbepoetin Alfa
n=9 Participants
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
69.8 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
72.2 years
STANDARD_DEVIATION 11.48 • n=7 Participants
|
69.1 years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 11.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6-7 months post initiation of dialysisEfficacy analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.Efficacy analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose of medication through 15 days post last dose (up to 8 months)Population: Safety Population
The adverse events are captured in the adverse event and serious adverse event section of this database.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=69 Participants
120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Epoetin Alfa
n=26 Participants
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Darbepoetin Alfa
n=9 Participants
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
|---|---|---|---|
|
Number of Participants Assessed for AEs and SAEs
|
69 participants
|
26 participants
|
9 participants
|
Adverse Events
Methoxy Polyethylene Glycol-epoetin Beta
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Epoetin Alfa
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Darbepoetin Alfa
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=69 participants at risk
120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Epoetin Alfa
n=26 participants at risk
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Darbepoetin Alfa
n=9 participants at risk
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
|---|---|---|---|
|
Cardiac disorders
atrial flutter
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Cardiac disorders
cardiac failure congestive
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
3.8%
1/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Gastrointestinal disorders
diabetic gastroparesis
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Gastrointestinal disorders
peptic ulcer perforation
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
3.8%
1/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Injury, poisoning and procedural complications
sternal fracture
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
3.8%
1/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Hepatobiliary disorders
cholecystitis acute
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Infections and infestations
catheter related infection
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Infections and infestations
cellulitis
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
3.8%
1/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Investigations
anticoagulation drug level above therapeutic
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Psychiatric disorders
mental status changes
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Renal and urinary disorders
renal impairment
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
Other adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=69 participants at risk
120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Epoetin Alfa
n=26 participants at risk
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
Darbepoetin Alfa
n=9 participants at risk
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
|
|---|---|---|---|
|
Renal and urinary disorders
urinary tract infection
|
4.3%
3/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
7.7%
2/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Gastrointestinal disorders
diarrhoea
|
5.8%
4/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
3.8%
1/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
General disorders
oedema peripheral
|
7.2%
5/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
General disorders
fatigue
|
2.9%
2/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
7.7%
2/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
2.9%
2/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
3.8%
1/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Gastrointestinal disorders
nausea
|
5.8%
4/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Skin and subcutaneous tissue disorders
skin laceration
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
7.7%
2/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Nervous system disorders
dizziness
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
1.4%
1/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
General disorders
ascites
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Cardiac disorders
bradycardia
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Psychiatric disorders
depression
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Gastrointestinal disorders
diverticulum
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
|
Vascular disorders
hypotension
|
0.00%
0/69 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
0.00%
0/26 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
11.1%
1/9 • First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
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