Trial Outcomes & Findings for A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients. (NCT NCT00413894)
NCT ID: NCT00413894
Last Updated: 2016-02-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
424 participants
Primary outcome timeframe
Visits 8 to 10 (Months 6 to 8)
Results posted on
2016-02-15
Participant Flow
A total of 661 participants with renal anemia due to chronic kidney disease (CKD) were enrolled; of which, 424 participants were treated with methoxy polyethylene glycol-epoetin beta (C.E.R.A) and are included in results.
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)
During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant's hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Overall Study
STARTED
|
424
|
|
Overall Study
COMPLETED
|
344
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)
During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant's hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Administrative Reasons
|
1
|
|
Overall Study
Hb <10 grams/deciliter
|
12
|
|
Overall Study
Adverse Event
|
28
|
|
Overall Study
Protocol Violation
|
11
|
|
Overall Study
Other
|
18
|
Baseline Characteristics
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Baseline characteristics by cohort
| Measure |
C.E.R.A
n=424 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visits 8 to 10 (Months 6 to 8)Population: Completer Population (CP) included only participants who completed the study until Visit 10 (Month 8).
Outcome measures
| Measure |
C.E.R.A
n=344 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase
|
31.7 percentage of participants
|
PRIMARY outcome
Timeframe: Visits 8 to 10 (Months 6 to 8)Population: CP
Outcome measures
| Measure |
C.E.R.A
n=344 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase
|
75.6 percentage of participants
|
PRIMARY outcome
Timeframe: Visits 8 to 10 (Months 6 to 8)Population: CP; number (n) equals (=) number of participants in the specified category
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Outcome measures
| Measure |
C.E.R.A
n=344 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase
Without Dose Modification (n=178)
|
44.9 percentage of participants
|
|
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase
With Dose Modification (n=166)
|
17.5 percentage of participants
|
PRIMARY outcome
Timeframe: Visits 8 to 10 (Months 6 to 8)Population: CP; n = number of participants in the specified category
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Outcome measures
| Measure |
C.E.R.A
n=344 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase
Without Dose Modification (n=178)
|
88.8 percentage of participants
|
|
Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase
With Dose Modification (n=166)
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: Visits 1 to 2 (Months -2 to -1)Population: ITT Population: All participants having received at least one dose of study medication and having at least one Hb value measurement under C.E.R.A. were included.
Outcome measures
| Measure |
C.E.R.A
n=416 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: Visits 1 to 2 (Months -2 to -1)Population: ITT Population
Outcome measures
| Measure |
C.E.R.A
n=416 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase
|
91.6 percentage of participants
|
SECONDARY outcome
Timeframe: Visits 1 to 2 (Months -2 to -1)Population: ITT Population; n = number of participants in the specified category
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Outcome measures
| Measure |
C.E.R.A
n=416 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase
Without Dose Modification (n=288)
|
43.4 percentage of participants
|
|
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase
With Dose Modification (n=128)
|
21.9 percentage of participants
|
SECONDARY outcome
Timeframe: Visits 1 to 2 (Months -2 to -1)Population: ITT Population; n = number of participants in the specified category
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Outcome measures
| Measure |
C.E.R.A
n=416 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase
Without Dose Modification (n=288)
|
93.1 percentage of participants
|
|
Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase
With Dose Modification (n=128)
|
88.3 percentage of participants
|
SECONDARY outcome
Timeframe: Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)Population: ITT Population;
Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase. Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted.
Outcome measures
| Measure |
C.E.R.A
n=416 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels
Category A
|
59.4 percentage of participants
|
|
Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels
Category B
|
19.5 percentage of participants
|
|
Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels
Category C
|
4.3 percentage of participants
|
|
Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels
Category D
|
14.9 percentage of participants
|
SECONDARY outcome
Timeframe: Visits 8 to 10 (Months 6 to 8)Population: ITT population
Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (\>) ±1.0 to ±1.5 g/dL, \> ±1.5 to ±2.0 g/dL, and \> ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.
Outcome measures
| Measure |
C.E.R.A
n=416 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hb Fluctuations Within Evaluation Phase
≤ ± 1.0 g/dl
|
82.9 percentage of participants
|
|
Percentage of Participants With Hb Fluctuations Within Evaluation Phase
> ± 1.0 to ± 1.5 g/d
|
7.9 percentage of participants
|
|
Percentage of Participants With Hb Fluctuations Within Evaluation Phase
> ± 1.5 to ± 2.0 g/dl
|
2.9 percentage of participants
|
|
Percentage of Participants With Hb Fluctuations Within Evaluation Phase
> ± 2.0 g/dl
|
0.5 percentage of participants
|
|
Percentage of Participants With Hb Fluctuations Within Evaluation Phase
Missing
|
5.8 percentage of participants
|
SECONDARY outcome
Timeframe: Visits 1 to 2 (Months -2 to -1)Population: ITT Population
Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, \>±1.0 to ±1.5 g/dL, \>±1.5 to ±2.0 g/dL, and \>±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.
Outcome measures
| Measure |
C.E.R.A
n=416 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants With Hb Fluctuations Within Screening Phase
≤ ± 1.0 g/dl
|
90.6 percentage of participants
|
|
Percentage of Participants With Hb Fluctuations Within Screening Phase
> ± 1.0 to ± 1.5 g/dl
|
8.7 percentage of participants
|
|
Percentage of Participants With Hb Fluctuations Within Screening Phase
> ± 1.5 to ± 2.0 g/dl
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Visits 1 to 10 (Months -2 to 8)Population: Safety Population (SAF): All participants who received at least one dose of study medication independent from whether they completed the study or not were included into the safety analysis.
Outcome measures
| Measure |
C.E.R.A
n=424 Participants
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Percentage of Participants Requiring Erythrocyte Transfusions
During Screening Phase
|
0.7 percentage of participants
|
|
Percentage of Participants Requiring Erythrocyte Transfusions
During Titration or Evaluation Phase
|
5.0 percentage of participants
|
Adverse Events
C.E.R.A
Serious events: 174 serious events
Other events: 173 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
C.E.R.A
n=424 participants at risk
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
7/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Angina Pectoris
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Angina Unstable
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Atrial Fibrillation
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Bradyarrhythmia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Coronary Artery Disease
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Mitral Valve Disease
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Myocardial Infarction
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Endocrine disorders
Goitre
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Endocrine disorders
Hyperparathyroidism Secondary
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Eye disorders
Glaucoma
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Eye disorders
Vitreous Haemorrhage
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Anal Fistula
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Dental Caries
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.71%
3/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Faecaloma
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Gastritis
|
0.71%
3/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer Haemorrhage
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Haematemesis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Intestinal Infarction
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Tooth Socket Haemorrhage
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Vomiting
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Application Site Dermatitis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Cardiac Death
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Chest Pain
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Drug Withdrawal Syndrome
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
General Physical Health Deterioration
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Oedema Peripheral
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Pain
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Ulcer Haemorrhage
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Hepatobiliary disorders
Cholangitis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Abscess Jaw
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Bronchitis Viral
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Catheter Related Infection
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Cellulitis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Device Related Infection
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Erysipelas
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Gangrene
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Gastroenteritis
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Gastroenteritis Clostridial
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Localised Infection
|
0.71%
3/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Paronychia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Pneumonia
|
1.4%
6/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Respiratory Tract Infection
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Sepsis
|
0.71%
3/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Shunt Infection
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Urosepsis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Haemorrhage
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Decompression Sickness
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Respiratory Fume Inhalation Disorder
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Shunt Aneurysm
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Shunt Blood Flow Excessive
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Shunt Malfunction
|
0.71%
3/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Shunt Occlusion
|
2.6%
11/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Shunt Stenosis
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Shunt Thrombosis
|
1.7%
7/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Injury, poisoning and procedural complications
Vascular Bypass Dysfunction
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Investigations
Arteriogram Coronary
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Investigations
Blood Pressure Increased
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Investigations
Haemoglobin Decreased
|
13.7%
58/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Investigations
Reticulocyte Count Decreased
|
0.71%
3/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Musculoskeletal and connective tissue disorders
Facet Joint Syndrome
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma Stage 0
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis Carcinoma
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Balance Disorder
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Convulsion
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Dementia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Epilepsy
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Somnolence
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Nervous system disorders
Syncope
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Psychiatric disorders
Cardiac Neurosis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Psychiatric disorders
Depression
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Renal and urinary disorders
Renal Cyst
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Renal and urinary disorders
Renal Failure
|
0.71%
3/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Renal and urinary disorders
Renal Failure Chronic
|
1.9%
8/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Reproductive system and breast disorders
Breast Mass
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.47%
2/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Surgical and medical procedures
Coronary Angioplasty
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Surgical and medical procedures
Large Intestine Anastomosis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Aortic Stenosis
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.71%
3/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Circulatory Collapse
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Haematoma
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Hypertension
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Ischaemia
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
1.2%
5/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Shock
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Subclavian Steal Syndrome
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Vascular disorders
Varicose Vein
|
0.24%
1/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
Other adverse events
| Measure |
C.E.R.A
n=424 participants at risk
During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant's hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant's Hb values.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.6%
49/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Nausea
|
8.5%
36/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
32/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
General disorders
Influenza Like Illness
|
5.0%
21/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
53/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Infections and infestations
Bronchitis
|
7.8%
33/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.0%
21/424 • Adverse events were recorded in the Safety Population from Day 1 of study drug administration until the end of follow-up period (up to 60 days after Visit 10)
|
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 after the first publication or presentation that involves the overall study. 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