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A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321919
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : May 25, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Intervention Drug: epoetin beta [NeoRecormon]
Enrollment 605
Recruitment Details This study was conducted from 26 July 2000 to 13 December 2004 at 94 centers in 21 countries.
Pre-assignment Details Of the 605 participants, 603 started the study; 2 were withdrawn from the study due to non-compliance with good clinical practice and were excluded from the analysis.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hemoglobin (Hb) level of 13-15 gram/decilitre (g/dL) with an individual Hb increase of at least 2 g/dL within approximately 3 months. Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL has occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Period Title: Overall Study
Started 301 302
Completed 226 250
Not Completed 75 52
Reason Not Completed
Adverse Event             17             10
Death             21             17
Insufficient Therapeutic Response             1             0
Violation of Selection Criteria at Entry             1             1
Refused Treatment             23             14
Other Protocol Violation             2             3
Failure to Return             3             1
Other withdrawal reason             7             6
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy Total
Hide Arm/Group Description Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months. Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL. Total of all reporting groups
Overall Number of Baseline Participants 301 302 603
Hide Baseline Analysis Population Description
Baseline characteristics were described for the intent-to-treat (ITT) population, which included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 302 participants 603 participants
59.3  (14.57) 58.8  (13.73) 59.0  (14.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 302 participants 603 participants
Female
130
  43.2%
148
  49.0%
278
  46.1%
Male
171
  56.8%
154
  51.0%
325
  53.9%
1.Primary Outcome
Title Median Time to First Cardiovascular Event
Hide Description The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data was not available due to insufficient number of participants with cardiovascular events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments The null hypothesis stated that there was no difference with regard to the event-free distribution of the combined endpoint of all protocol specified cardiovascular events between Early Epoetin beta therapy and Late Epoetin beta therapy groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2036
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.778976
Confidence Interval (2-Sided) 95%
0.53 to 1.14
Estimation Comments The Cox regression model was used to estimate the relative risk of the time to first cardiovascular event in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.
2.Secondary Outcome
Title Median Time to Death Due to Cardiovascular Events
Hide Description Time to death due to cardiovascular events is the time determined between randomization and death due to cardiovascular events.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data was not available due to insufficient number of deaths due to cardiovascular events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4833
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.744575
Confidence Interval (2-Sided) 95%
0.33 to 1.70
Estimation Comments The Cox regression model was used to estimate the relative risk of an event of the time to death due to cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.
3.Secondary Outcome
Title Number of Participants Who Died Due to Cardiovascular Events
Hide Description The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Measure Type: Number
Unit of Measure: participants
Total Cardiovascular Death Events 8 6
Cardiac Failure 1 2
Cardiac Failure Acute 1 2
Acute Myocardial Infarction 1 1
Angina Pectoris 1 0
Arrhythmia 1 0
Cardiac Arrest 1 0
Cardio-Respiratory Arrest 1 0
Cardiopulmonary Failure 1 0
Myocardial Infarction 0 1
4.Secondary Outcome
Title Median Time to Death Due to All Causes
Hide Description Time to death due to all causes is the time determined between randomization and death due to all causes.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data was not available due to insufficient number of deaths due to all causes.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1391
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.658259
Confidence Interval (2-Sided) 95%
0.38 to 1.15
Estimation Comments The Cox regression model was used to estimate the relative risk of the time to death for all causes in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy treatment group.
5.Secondary Outcome
Title Number of Participants Who Died Due to All Causes
Hide Description Number of participants who died due to all causes are presented in table below.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Measure Type: Number
Unit of Measure: participants
Total Death Events for All-cause 31 21
Sudden Death 4 2
Cerebrovascular Accident 2 2
Cardiac Failure 1 2
Cardiac Failure Acute 1 2
Sepsis 1 2
Acute Myocardial Infarction 1 1
Bronchopneumonia 1 1
Respiratory Failure 1 1
Septic Shock 2 0
Acute Heart Failure 1 0
Acute Respiratory Failure 0 1
Angina Pectoris 1 0
Arrhythmia 1 0
Cardiac Arrest 1 0
Cardio-Respiratory Arrest 1 0
Cardiopulmonary Failure 1 0
Cerebral Infarction 1 0
Clostridial Infection 1 0
Colon Cancer Metastatic 0 1
Embolic Stroke 1 0
Intestinal Infarction 0 1
Intestinal Ischaemia 0 1
Laryngeal Cancer 1 0
Lung Neoplasm Malignant 0 1
Metastases To Lung 1 0
Metastatic Neoplasm 1 0
Myocardial Infarction 0 1
Oesophageal Carcinoma 1 0
Peripheral Vascular Disorder 1 0
Pneumonia 0 1
Pulmonary Embolism 0 1
Renal Failure 1 0
Unevaluable Event 1 0
Uraemic Encephalopathy 1 0
6.Secondary Outcome
Title Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)
Hide Description The NYHA functional classification assesses the severity of symptoms of chronic heart failure and is comprised of four classes. Class I is defined as no limitation of physical activity, Class II is defined as slight limitation of physical activity, Class III is defined as marked limitation of physical activity, and Class IV is defined as unable to carry on any physical activity without discomfort. Shifts of participants from CL 0, CL I, CL II, CL III, CL IV at Baseline (Day 1) to CL 0, CL I, CL II, CL III, CL IV during the study period was determined and presented.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The "n" represents the number of participants assessed for shifts in NYHA class from baseline.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 167 149
Measure Type: Number
Unit of Measure: participants
From CL 0 (BL) to CL 0; n = 167, 149 49 42
From CL 0 (BL) to CL I; n = 167, 149 7 4
From CL 0 (BL) to CL II; n = 167, 149 7 7
From CL 0 (BL) to CL III; n = 167, 149 2 1
From CL 0 (BL) to CL IV; n = 167, 149 0 0
From CL I (BL) to CL 0; n = 37, 43 1 0
From CL I (BL) to CL I; n = 37, 43 28 34
From CL I (BL) to CL II; n = 37, 43 5 4
From CL I (BL) to CL III; n = 37, 43 0 0
From CL I (BL) to CL IV; n = 37, 43 0 0
From CL II (BL) to CL 0; n = 53, 44 0 0
From CL II (BL) to CL I; n = 53, 44 5 1
From CL II (BL) to CL II; n = 53, 44 39 37
From CL II (BL) to CL III; n = 53, 44 2 4
From CL II (BL) to CL IV; n = 53, 44 0 0
From CL III (BL) to CL 0; n = 0, 0 0 0
From CL III (BL)to CL I; n = 0, 0 0 0
From CL III (BL)to CL II; n = 0, 0 0 0
From CL III (BL)to CL III; n = 0, 0 0 0
From CL III (BL)to CL IV; n = 0, 0 0 0
From CL IV (BL)to CL 0; n = 0, 0 0 0
From CL IV (BL)to CL I; n = 0, 0 0 0
From CL IV (BL)to CL II; n = 0, 0 0 0
From CL IV (BL)to CL III; n = 0, 0 0 0
From CL IV (BL)to CL IV; n = 0, 0 0 0
7.Secondary Outcome
Title Median Time to First Cardiovascular Intervention
Hide Description Time to first cardiovascular intervention is the time between randomization and first intervention determined for all cardiovascular interventions after randomization. Cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data was not available due to insufficient number of cardiovascular interventions.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4985
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.804594
Confidence Interval (2-Sided) 95%
0.43 to 1.51
Estimation Comments The Cox regression model was used to estimate the relative risk of time to first cardiovascular intervention in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group
8.Secondary Outcome
Title Total Number of Cardiovascular Intervention
Hide Description Cardiovascular intervention was defined by a clinical review of all concomitant treatments. The cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. The total number of cardiovascular intervention was determined and presented by each cohort.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Measure Type: Number
Unit of Measure: number of cardiovascular intervention
21 18
9.Secondary Outcome
Title Median Time to First Hospitalization Due to Cardiovascular Events
Hide Description Time to first hospitalization due to cardiovascular events is defined as the time determined between randomization and first hospitalization due to cardiovascular events.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Median (Inter-Quartile Range)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data was not available due to insufficient number of hospitalizations due to cardiovascular events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3419
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.82046
Confidence Interval (2-Sided) 95%
0.55 to 1.23
Estimation Comments The Cox regression model was used to estimate the relative risk of the time to first hospitalization for cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.
10.Secondary Outcome
Title Duration of Hospitalization for Cardiovascular Events
Hide Description The duration of hospitalization was the total number of days that a participant was hospitalized due to cardiovascular events. Participants with no hospitalization were excluded from analysis.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. Data for the participants present at the time of assessment was used for analysis.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 171 161
Mean (Standard Deviation)
Unit of Measure: days
33.0  (42.0) 28.2  (33.7)
11.Secondary Outcome
Title Mean Change From Baseline in Left Ventricular Mass Index (LVMI)
Hide Description LVMI is determined by echocardiogram. LVMI indexed to body surface area (gram/square meter) estimated by LV cavity dimension and wall thickness at end-diastole. The change was calculated as week value minus baseline value.
Time Frame Baseline, Week 12, Week 24, Week 36, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The "n" represents the number of participants assessed for LVMI at Baseline, Week 12, Week 24, Week 36, and Week 48.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 219 232
Mean (Standard Deviation)
Unit of Measure: gram/square meter
LVMI, Baseline; n = 219, 232 120.32  (35.03) 117.97  (34.34)
LVMI, Week 12; n = 171, 186 -5.06  (24.81) -2.87  (25.16)
LVMI, Week 24; n = 136, 146 -6.58  (26.94) -7.59  (25.59)
LVMI, Week 36; n = 74, 81 -1.30  (36.04) -7.53  (34.37)
LVMI, Week 48; n = 2, 11 2.00  (2.83) -27.27  (29.47)
12.Secondary Outcome
Title Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)
Hide Description LVEF is a marker of left ventricular systolic function and determined by echocardiogram. It is expressed as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage. FS is used as an estimate of myocardial contractility and determined by echocardiogram and measures as a percentage. The change for LVEF and FS was calculated as Week value minus baseline value.
Time Frame Baseline, Week 12, Week 24, Week 36, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The "n" represents the number of participants assessed for LVEF and FS at Baseline, Week 12, Week 24, Week 36, and Week 48.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 219 233
Mean (Standard Deviation)
Unit of Measure: percentage
LVEF, Baseline; n = 219, 233 81.31  (7.24) 81.95  (7.75)
LVEF, Week 12; n = 170, 186 -0.08  (7.32) 0.08  (7.34)
LVEF, Week 24; n = 135, 147 -0.47  (6.82) -0.23  (7.01)
LVEF, Week 36; n = 74, 81 -0.61  (8.61) 0.24  (6.75)
LVEF, Week 48; n = 2,11 -0.46  (2.92) 2.80  (8.12)
FS, Baseline; n = 219, 232 43.67  (7.12) 44.67  (7.86)
FS, Week 12; n = 196, 212 0.13  (6.79) 0.08  (7.34)
FS, Week 24; n = 174, 192 0.11  (7.10) -0.19  (7.40)
FS, Week 36; n = 98, 105 0.05  (8.16) 0.70  (7.80)
FS, Week 48; n = 4,12 1.00  (2.83) 3.00  (8.58)
13.Secondary Outcome
Title Mean Change From Baseline in Left Ventricular Volume (LV Volume )
Hide Description Left Ventricular Volume is the estimated of left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) determined by Echocardiogram. The change was calculated as week value minus baseline value.
Time Frame Baseline, Week 12, Week 24, Week 36, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The "n" represents the number of participants assessed for LV Volume at Baseline, Week 12, Week 24, Week 36 and Week 48.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 218 232
Mean (Standard Deviation)
Unit of Measure: milliliters per meter square
LV Volume, Baseline; n = 218, 232 67.73  (19.20) 65.11  (19.24)
LV Volume, Week 12; n = 170, 186 -2.83  (15.90) 3.15  (15.46)
LV Volume, Week 24; n = 134, 146 -0.69  (16.44) 2.62  (18.56)
LV Volume, Week 36; n = 72, 80 3.34  (24.29) 4.05  (19.08)
LV Volume, Week 48; n = 2, 11 14.48  (11.52) 7.91  (23.37)
14.Secondary Outcome
Title Mean Values of Echocardiography Parameters
Hide Description Mean values of Echocardiography (ECHO) Parameters: Left Ventricular End Diastolic Diameter (LVEDD), Left Ventricular Posterior Wall Thickness (LVPWT), IV Septal Wall Thickness (IVSWT), LV End Systolic Diameter (LVESD), LV Relative wall thickness (LVRWT) at Baseline, Year 1, Year 2, Year 3 and Year 4 were presented.
Time Frame Baseline, Year 1, Year 2, Year 3, and Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The "n" represents the number of participants assessed for each echocardiography parameter at Baseline, Year 1, Year 2, Year 3 and Year 4.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 219 233
Mean (Standard Deviation)
Unit of Measure: centimeters
LVEDD, Baseline, n = 219, 233 5.05  (0.67) 4.91  (0.68)
LVEDD, Year 1, n = 170, 186 4.93  (0.62) 4.94  (0.65)
LVEDD, Year 2, n = 135, 147 4.95  (0.63) 4.93  (0.72)
LVEDD, Year 3, n = 74, 81 5.09  (0.71) 4.88  (0.59)
LVEDD, Year 4, n = 2,11 5.21  (0.30) 5.08  (0.79)
LVPWT, Baseline, n = 219, 233 1.05  (0.17) 1.05  (0.17)
LVPWT, Year 1, n = 170, 186 1.02  (0.17) 1.01  (0.16)
LVPWT, Year 2, n= 135, 147 1.01  (0.13) 0.99  (0.14)
LVPWT, Year 3, n = 74, 81 1.01  (0.17) 1.00  (0.13)
LVPWT, Year 4, n = 2,11 1.08  (0.13) 0.92  (0.16)
IVSWT, Baseline, n = 219, 233 1.18  (0.24) 1.20  (0.28)
IVSWT, Year 1, n = 170, 186 1.17  (0.23) 1.13  (0.24)
IVSWT, Year 2, n = 135, 147 1.12  (0.21) 1.11  (0.20)
IVSWT, Year 3, n = 74, 81 1.14  (0.25) 1.12  (0.22)
IVSWT, Year 4, n = 2, 11 1.30  (0.05) 1.04  (0.20)
LVESD, Baseline, n = 219, 233 2.85  (0.58) 2.74  (0.66)
LVESD, Year 1, n = 170, 186 2.76  (0.56) 2.73  (0.62)
LVESD, Year 2, n = 135, 147 2.78  (0.58) 2.75  (0.68)
LVESD, Year 3, n = 74, 81 2.88  (0.75) 2.67  (0.59)
LVESD, Year 4, n = 2, 11 2.93  (0.22) 2.84  (0.57)
LVRWT, Baseline, n = 219, 233 0.42  (0.08) 0.43  (0.09)
LVRWT, Year 1, n = 170, 186 0.42  (0.08) 0.41  (0.08)
LVRWT, Year 2, n = 135, 147 0.41  (0.06) 0.41  (0.07)
LVRWT, Year 3, n = 74, 81 0.41  (0.09) 0.42  (0.07)
LVRWT, Year 4, n = 2, 11 0.41  (0.03) 0.37  (0.07)
15.Secondary Outcome
Title Mean Values of Body Surface Area
Hide Description The body surface area (BSA) was determined by Echocardiogram. Absolute mean values of Echocardiography (ECHO) Parameter: Body surface area (BSA) at Baseline, Year 1, Year 2, Year 3 and Year 4 were calculated and presented.
Time Frame Baseline, Year 1, Year 2, Year 3, and Year 4.
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The "n" represents the number of participants assessed for Body surface area through echocardiogram at Baseline, Year 1, Year 2, Year 3 and Year 4.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 287 290
Mean (Standard Deviation)
Unit of Measure: Square meter
BSA, Baseline, n = 287, 290 1.83  (0.22) 1.79  (0.20)
BSA, Year 1, n = 257, 261 1.83  (0.22) 1.77  (0.23)
BSA, Year 2, n = 224, 234 1.82  (0.21) 1.77  (0.19)
BSA, Year 3, n = 116, 121 1.82  (0.21) 1.72  (0.19)
BSA, Year 4, n = 4, 11 1.96  (0.21) 1.76  (0.22)
16.Secondary Outcome
Title Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire
Hide Description The Quality of life was assessed on the basis of a change from baseline in the scores of each of the eight health scales in the SF-36 questionnaire. The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well-being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health (GH), vitality, mental health. The score for a section is an average of the individual question scores, which are scaled from 0 (worst level of functioning) to 100 (100=best level of functioning). The least squares mean (LSM) change from baseline was determined by Analysis of covariance (ANCOVA) model and presented for each of the eight health scale.
Time Frame Baseline, Year 1, and Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 301 302
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
General Health, Year 1 4.1  (1.01) -0.1  (0.99)
General Health, Year 2 2.3  (1.14) -1.9  (1.08)
Mental Health, Year 1 2.7  (0.98) -2.1  (0.96)
Mental Health, Year 2 2.0  (1.07) -0.4  (1.02)
Physical Function, Year 1 3.5  (1.1) -2.1  (1.1)
Physical Function, Year 2 -2.5  (1.33) -2.5  (1.27)
Physical Role, Year 1 2.6  (2.23) -5.5  (2.20)
Physical Role, Year 2 -2.3  (2.59) -7.3  (2.47)
Social Function, Year 1 1.8  (1.23) -3.0  (1.21)
Social Function, Year 2 -0.1  (1.44) -3.0  (1.37)
Vitality Function, Year 1 3.9  (0.97) -0.6  (0.95)
Vitality Function, Year 2 2.8  (1.10) -1.0  (1.05)
Bodily Pain, Year 1 -0.2  (1.37) -2.1  (1.35)
Bodily Pain, Year 2 -2.0  (1.53) -1.2  (1.46)
Emotional Role, Year 1 0.4  (2.17) -4.3  (2.14)
Emotional Role, Year 2 -0.1  (2.51) -2.2  (2.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of General health scale of Quality of life for Year 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of General health scale of Quality of life for Year 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0081
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Mental health scale of Quality of life for Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Mental Health scale of Quality of life for Year 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0965
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9864
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0097
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1670
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1455
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0123
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3155
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7076
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1291
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Early Epoetin Beta Therapy, Late Epoetin Beta Therapy
Comments Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5528
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
17.Secondary Outcome
Title Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs
Hide Description Anti-hypertensive is defined as class of drugs that are used to treat hypertension. Numbers (No.) of participants treated with at least one hypertensive medication/Treatment (Tt) according to class of drugs were reported.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 300 302
Measure Type: Number
Unit of Measure: participants
No. of participants with at least one Tt 287 282
Calcium Channel Blocking Agents 201 204
Loop Diuretics 183 180
Angiotensin-Converting Enzyme Inhibitors 158 153
Beta-Adrenoceptor Blocking Agents 169 136
Angiotensin-II Receptor Antagonists 89 96
Alpha-Adrenoreceptor Antagonists 87 73
Antihypertensive Agents 55 52
Thiazide And Related Diuretics 44 40
Antianginal Agents 6 5
Potassium Sparing Diuretics 4 7
Aldosterone Antagonists 2 5
Cardiac Glycosides 1 1
Diuretics 2 0
Supplements 1 1
Calcium Compounds And Regulators 0 1
Miscellaneous Drugs 0 1
Tricyclic Antidepressants 1 0
18.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities
Hide Description Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Values above and below the given reference range were determined as High or Low range values of the laboratory parameter. Roche's standard reference ranges for laboratory test parameters were used for the analysis. The laboratory parameters with marked abnormality are platelets (reference range is 150-350 10^9 cells/liter [L]), creatinine (reference range is 0-133 micromole per liter), albumin (reference range is 35.0-55 g/L), phosphate (reference range is 0.84-1.45 millimole per liter [mmol /L]) and potassium (reference range is 3.4-4.8 mmol /L).
Time Frame Baseline, every 3 months up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment. The ''n" represents the number of participants assessed for each laboratory parameter.
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description:
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Overall Number of Participants Analyzed 206 208
Measure Type: Number
Unit of Measure: participants
Platelets - High; n = 206, 208 5 0
Platelets - Low; n = 206, 208 13 15
Creatinine - High; n = 206, 208 140 128
Albumin - Low; n = 201, 205 6 9
Phosphate - High; n = 206, 208 164 150
Phosphate - Low; n = 206, 208 22 23
Potassium - High; n = 206, 208 47 46
Potassium - Low; n = 206, 208 4 6
Time Frame Up to 4 years
Adverse Event Reporting Description An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
 
Arm/Group Title Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Hide Arm/Group Description Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months. Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
All-Cause Mortality
Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   158/300 (52.67%)   145/302 (48.01%) 
Blood and lymphatic system disorders     
Anaemia  1  3/300 (1.00%)  6/302 (1.99%) 
Leukopenia  1  1/300 (0.33%)  0/302 (0.00%) 
Nephrogenic Anaemia  1  1/300 (0.33%)  0/302 (0.00%) 
Neutropenia  1  0/300 (0.00%)  1/302 (0.33%) 
Cardiac disorders     
Arrhythmia  1  16/300 (5.33%)  14/302 (4.64%) 
Cardiac Failure Acute  1  11/300 (3.67%)  19/302 (6.29%) 
Myocardial Infarction  1  13/300 (4.33%)  14/302 (4.64%) 
Angina Pectoris  1  11/300 (3.67%)  4/302 (1.32%) 
Cardiac Arrest  1  2/300 (0.67%)  0/302 (0.00%) 
Cardiac Failure Chronic  1  0/300 (0.00%)  1/302 (0.33%) 
Cardiac Failure Congestive  1  0/300 (0.00%)  1/302 (0.33%) 
Cardiopulmonary Failure  1  1/300 (0.33%)  0/302 (0.00%) 
Coronary Artery Occlusion  1  1/300 (0.33%)  0/302 (0.00%) 
Coronary Artery Stenosis  1  1/300 (0.33%)  1/302 (0.33%) 
Myocarditis  1  1/300 (0.33%)  0/302 (0.00%) 
Pericardial Effusion  1  0/300 (0.00%)  1/302 (0.33%) 
Congenital, familial and genetic disorders     
Congenital Cystic Kidney Disease  1  1/300 (0.33%)  0/302 (0.00%) 
Polycystic Liver Disease  1  0/300 (0.00%)  1/302 (0.33%) 
Ear and labyrinth disorders     
Vestibular Neuronitis  1  1/300 (0.33%)  0/302 (0.00%) 
Endocrine disorders     
Hyperparathyroidism  1  0/300 (0.00%)  2/302 (0.66%) 
Hyperparathyroidism Secondary  1  2/300 (0.67%)  0/302 (0.00%) 
Hyperthyroidism  1  0/300 (0.00%)  1/302 (0.33%) 
Eye disorders     
Retinal Detachment  1  1/300 (0.33%)  1/302 (0.33%) 
Cataract  1  0/300 (0.00%)  1/302 (0.33%) 
Glaucoma  1  1/300 (0.33%)  0/302 (0.00%) 
Ocular Hypertension  1  0/300 (0.00%)  1/302 (0.33%) 
Strabismus  1  0/300 (0.00%)  1/302 (0.33%) 
Vitreous Haemorrhage  1  0/300 (0.00%)  1/302 (0.33%) 
Gastrointestinal disorders     
Peritonitis  1  4/300 (1.33%)  3/302 (0.99%) 
Abdominal Pain  1  0/300 (0.00%)  5/302 (1.66%) 
Vomiting  1  1/300 (0.33%)  4/302 (1.32%) 
Diarrhoea  1  2/300 (0.67%)  2/302 (0.66%) 
Gastrointestinal Haemorrhage  1  3/300 (1.00%)  1/302 (0.33%) 
Pancreatitis Acute  1  1/300 (0.33%)  3/302 (0.99%) 
Gastritis  1  3/300 (1.00%)  0/302 (0.00%) 
Intestinal Ischaemia  1  1/300 (0.33%)  2/302 (0.66%) 
Constipation  1  2/300 (0.67%)  0/302 (0.00%) 
Diverticulum Intestinal  1  2/300 (0.67%)  0/302 (0.00%) 
Haemorrhoids  1  0/300 (0.00%)  2/302 (0.66%) 
Ileus  1  1/300 (0.33%)  1/302 (0.33%) 
Inguinal Hernia  1  2/300 (0.67%)  0/302 (0.00%) 
Abdominal Haematoma  1  1/300 (0.33%)  0/302 (0.00%) 
Abdominal Hernia  1  1/300 (0.33%)  0/302 (0.00%) 
Abdominal Symptom  1  1/300 (0.33%)  0/302 (0.00%) 
Colitis  1  1/300 (0.33%)  0/302 (0.00%) 
Colitis Ulcerative  1  0/300 (0.00%)  1/302 (0.33%) 
Colonic Polyp  1  1/300 (0.33%)  0/302 (0.00%) 
Diverticular Perforation  1  0/300 (0.00%)  1/302 (0.33%) 
Duodenal Ulcer  1  1/300 (0.33%)  0/302 (0.00%) 
Duodenitis Haemorrhagic  1  1/300 (0.33%)  0/302 (0.00%) 
Dyspepsia  1  1/300 (0.33%)  0/302 (0.00%) 
Enteritis  1  1/300 (0.33%)  0/302 (0.00%) 
Erosive Duodenitis  1  1/300 (0.33%)  0/302 (0.00%) 
Gastric Haemorrhage  1  0/300 (0.00%)  1/302 (0.33%) 
Gastric Ulcer  1  0/300 (0.00%)  1/302 (0.33%) 
Haematemesis  1  1/300 (0.33%)  0/302 (0.00%) 
Haematochezia  1  1/300 (0.33%)  0/302 (0.00%) 
Ileus Paralytic  1  0/300 (0.00%)  1/302 (0.33%) 
Intestinal Obstruction  1  1/300 (0.33%)  0/302 (0.00%) 
Nausea  1  1/300 (0.33%)  0/302 (0.00%) 
Oesophagitis  1  0/300 (0.00%)  1/302 (0.33%) 
Pancreatitis Chronic  1  0/300 (0.00%)  1/302 (0.33%) 
Peptic Ulcer  1  0/300 (0.00%)  1/302 (0.33%) 
Reflux Oesophagitis  1  1/300 (0.33%)  0/302 (0.00%) 
General disorders     
Pyrexia  1  3/300 (1.00%)  4/302 (1.32%) 
Sudden Death  1  4/300 (1.33%)  2/302 (0.66%) 
Oedema Peripheral  1  3/300 (1.00%)  1/302 (0.33%) 
Chest Pain  1  3/300 (1.00%)  0/302 (0.00%) 
Asthenia  1  1/300 (0.33%)  1/302 (0.33%) 
Catheter Related Complication  1  1/300 (0.33%)  1/302 (0.33%) 
General Physical Health Deterioration  1  0/300 (0.00%)  2/302 (0.66%) 
Oedema  1  1/300 (0.33%)  1/302 (0.33%) 
Adverse Drug Reaction  1  0/300 (0.00%)  1/302 (0.33%) 
Catheter Site Inflammation  1  1/300 (0.33%)  0/302 (0.00%) 
Chills  1  1/300 (0.33%)  0/302 (0.00%) 
Fatigue  1  0/300 (0.00%)  1/302 (0.33%) 
Heparin-Induced Thrombocytopenia  1  1/300 (0.33%)  0/302 (0.00%) 
Injection Site Thrombosis  1  1/300 (0.33%)  0/302 (0.00%) 
Hepatobiliary disorders     
Cholecystitis Acute  1  2/300 (0.67%)  3/302 (0.99%) 
Cholelithiasis  1  1/300 (0.33%)  2/302 (0.66%) 
Cholecystitis  1  0/300 (0.00%)  2/302 (0.66%) 
Cholestasis Of Pregnancy  1  1/300 (0.33%)  0/302 (0.00%) 
Hepatic Cyst  1  1/300 (0.33%)  0/302 (0.00%) 
Hyperbilirubinaemia  1  0/300 (0.00%)  1/302 (0.33%) 
Jaundice  1  0/300 (0.00%)  1/302 (0.33%) 
Immune system disorders     
Amyloidosis  1  1/300 (0.33%)  0/302 (0.00%) 
Kidney Transplant Rejection  1  1/300 (0.33%)  0/302 (0.00%) 
Infections and infestations     
Pneumonia  1  9/300 (3.00%)  9/302 (2.98%) 
Urinary Tract Infection  1  4/300 (1.33%)  8/302 (2.65%) 
Sepsis  1  6/300 (2.00%)  3/302 (0.99%) 
Gastroenteritis  1  2/300 (0.67%)  4/302 (1.32%) 
Renal Cyst Infection  1  1/300 (0.33%)  4/302 (1.32%) 
Appendicitis  1  2/300 (0.67%)  2/302 (0.66%) 
Upper Respiratory Tract Infection  1  2/300 (0.67%)  2/302 (0.66%) 
Erysipelas  1  2/300 (0.67%)  1/302 (0.33%) 
Respiratory Tract Infection  1  1/300 (0.33%)  2/302 (0.66%) 
Abscess Limb  1  0/300 (0.00%)  2/302 (0.66%) 
Bacteraemia  1  2/300 (0.67%)  0/302 (0.00%) 
Bronchopneumonia  1  1/300 (0.33%)  1/302 (0.33%) 
Catheter Related Infection  1  2/300 (0.67%)  0/302 (0.00%) 
Catheter Site Infection  1  1/300 (0.33%)  1/302 (0.33%) 
Diverticulitis  1  1/300 (0.33%)  1/302 (0.33%) 
Herpes Zoster  1  1/300 (0.33%)  1/302 (0.33%) 
Pyelonephritis  1  2/300 (0.67%)  0/302 (0.00%) 
Pyelonephritis Acute  1  1/300 (0.33%)  1/302 (0.33%) 
Sepsis Syndrome  1  2/300 (0.67%)  0/302 (0.00%) 
Bronchitis Acute  1  0/300 (0.00%)  1/302 (0.33%) 
Catheter Sepsis  1  0/300 (0.00%)  1/302 (0.33%) 
Cellulitis  1  0/300 (0.00%)  1/302 (0.33%) 
Cholecystitis Infective  1  1/300 (0.33%)  0/302 (0.00%) 
Clostridial Infection  1  1/300 (0.33%)  0/302 (0.00%) 
Epidemic Nephropathy  1  0/300 (0.00%)  1/302 (0.33%) 
Escherichia Sepsis  1  1/300 (0.33%)  0/302 (0.00%) 
Fungal Peritonitis  1  0/300 (0.00%)  1/302 (0.33%) 
Hepatic Cyst Infection  1  1/300 (0.33%)  0/302 (0.00%) 
Hepatitis C  1  1/300 (0.33%)  0/302 (0.00%) 
Infected Skin Ulcer  1  0/300 (0.00%)  1/302 (0.33%) 
Infection  1  1/300 (0.33%)  0/302 (0.00%) 
Kidney Infection  1  1/300 (0.33%)  0/302 (0.00%) 
Localised Infection  1  0/300 (0.00%)  2/302 (0.66%) 
Lower Respiratory Tract Infection  1  1/300 (0.33%)  0/302 (0.00%) 
Lung Infection  1  0/300 (0.00%)  1/302 (0.33%) 
Pneumonia Fungal  1  1/300 (0.33%)  0/302 (0.00%) 
Sialoadenitis  1  1/300 (0.33%)  0/302 (0.00%) 
Staphylococcal Sepsis  1  0/300 (0.00%)  1/302 (0.33%) 
Streptococcal Sepsis  1  1/300 (0.33%)  0/302 (0.00%) 
Urosepsis  1  1/300 (0.33%)  0/302 (0.00%) 
Wound Infection  1  0/300 (0.00%)  1/302 (0.33%) 
Injury, poisoning and procedural complications     
Arteriovenous Fistula Thrombosis  1  0/300 (0.00%)  4/302 (1.32%) 
Hip Fracture  1  1/300 (0.33%)  3/302 (0.99%) 
Arteriovenous Fistula Site Complication  1  3/300 (1.00%)  0/302 (0.00%) 
Complications Of Transplanted Kidney  1  1/300 (0.33%)  1/302 (0.33%) 
Femoral Neck Fracture  1  2/300 (0.67%)  0/302 (0.00%) 
Head Injury  1  1/300 (0.33%)  1/302 (0.33%) 
Humerus Fracture  1  1/300 (0.33%)  1/302 (0.33%) 
Acetabulum Fracture  1  0/300 (0.00%)  1/302 (0.33%) 
Arterial Injury  1  1/300 (0.33%)  0/302 (0.00%) 
Arteriovenous Fistula Site Haemorrhage  1  1/300 (0.33%)  0/302 (0.00%) 
Cardiac Pacemaker Malfunction  1  0/300 (0.00%)  1/302 (0.33%) 
Concussion  1  0/300 (0.00%)  1/302 (0.33%) 
Eye Injury  1  1/300 (0.33%)  0/302 (0.00%) 
Femur Fracture  1  0/300 (0.00%)  1/302 (0.33%) 
Injury  1  1/300 (0.33%)  0/302 (0.00%) 
Joint Injury  1  1/300 (0.33%)  0/302 (0.00%) 
Medical Device Complication  1  1/300 (0.33%)  0/302 (0.00%) 
Medication Error  1  1/300 (0.33%)  0/302 (0.00%) 
Multiple Fractures  1  0/300 (0.00%)  1/302 (0.33%) 
Open Wound  1  1/300 (0.33%)  0/302 (0.00%) 
Post Procedural Haematoma  1  1/300 (0.33%)  0/302 (0.00%) 
Post Procedural Haemorrhage  1  1/300 (0.33%)  0/302 (0.00%) 
Postoperative Hernia  1  0/300 (0.00%)  1/302 (0.33%) 
Procedural Complication  1  1/300 (0.33%)  0/302 (0.00%) 
Renal Haematoma  1  1/300 (0.33%)  0/302 (0.00%) 
Shunt Thrombosis  1  1/300 (0.33%)  0/302 (0.00%) 
Subdural Haematoma  1  1/300 (0.33%)  0/302 (0.00%) 
Subdural Haemorrhage  1  1/300 (0.33%)  0/302 (0.00%) 
Vascular Access Complication  1  0/300 (0.00%)  1/302 (0.33%) 
Investigations     
Blood Pressure Increased  1  3/300 (1.00%)  0/302 (0.00%) 
Biopsy Liver  1  1/300 (0.33%)  0/302 (0.00%) 
Blood Creatine Phosphokinase Increased  1  0/300 (0.00%)  1/302 (0.33%) 
Transaminases Increased  1  0/300 (0.00%)  1/302 (0.33%) 
Urine Cytology Abnormal  1  1/300 (0.33%)  0/302 (0.00%) 
Weight Decreased  1  1/300 (0.33%)  0/302 (0.00%) 
Weight Increased  1  0/300 (0.00%)  1/302 (0.33%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  6/300 (2.00%)  1/302 (0.33%) 
Hyperkalaemia  1  3/300 (1.00%)  1/302 (0.33%) 
Dehydration  1  1/300 (0.33%)  2/302 (0.66%) 
Diabetes Mellitus Inadequate Control  1  2/300 (0.67%)  1/302 (0.33%) 
Fluid Overload  1  3/300 (1.00%)  0/302 (0.00%) 
Fluid Retention  1  2/300 (0.67%)  1/302 (0.33%) 
Hyperglycaemia  1  0/300 (0.00%)  3/302 (0.99%) 
Metabolic Acidosis  1  2/300 (0.67%)  1/302 (0.33%) 
Diabetes Mellitus  1  1/300 (0.33%)  1/302 (0.33%) 
Diabetic Foot  1  0/300 (0.00%)  1/302 (0.33%) 
Diabetic Ketoacidosis  1  1/300 (0.33%)  0/302 (0.00%) 
Electrolyte Imbalance  1  0/300 (0.00%)  1/302 (0.33%) 
Gout  1  1/300 (0.33%)  0/302 (0.00%) 
Hyponatraemia  1  1/300 (0.33%)  0/302 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  4/300 (1.33%)  0/302 (0.00%) 
Localised Osteoarthritis  1  2/300 (0.67%)  1/302 (0.33%) 
Myalgia  1  2/300 (0.67%)  0/302 (0.00%) 
Pain In Extremity  1  0/300 (0.00%)  2/302 (0.66%) 
Arthralgia  1  0/300 (0.00%)  1/302 (0.33%) 
Arthritis  1  1/300 (0.33%)  0/302 (0.00%) 
Gouty Arthritis  1  0/300 (0.00%)  1/302 (0.33%) 
Joint Swelling  1  1/300 (0.33%)  0/302 (0.00%) 
Muscular Weakness  1  0/300 (0.00%)  1/302 (0.33%) 
Musculoskeletal Chest Pain  1  0/300 (0.00%)  1/302 (0.33%) 
Myopathy  1  1/300 (0.33%)  0/302 (0.00%) 
Osteoarthritis  1  0/300 (0.00%)  1/302 (0.33%) 
Osteoarthropathy  1  0/300 (0.00%)  1/302 (0.33%) 
Rhabdomyolysis  1  1/300 (0.33%)  0/302 (0.00%) 
Tendonitis  1  0/300 (0.00%)  1/302 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer  1  2/300 (0.67%)  1/302 (0.33%) 
Prostate Cancer  1  1/300 (0.33%)  2/302 (0.66%) 
Renal Cell Carcinoma Stage Unspecified  1  1/300 (0.33%)  2/302 (0.66%) 
Colon Cancer  1  0/300 (0.00%)  2/302 (0.66%) 
Lung Neoplasm Malignant  1  1/300 (0.33%)  1/302 (0.33%) 
Bladder Neoplasm  1  1/300 (0.33%)  0/302 (0.00%) 
Breast Cancer  1  0/300 (0.00%)  1/302 (0.33%) 
Breast Neoplasm  1  0/300 (0.00%)  1/302 (0.33%) 
Cervix Carcinoma  1  1/300 (0.33%)  0/302 (0.00%) 
Colon Adenoma  1  1/300 (0.33%)  0/302 (0.00%) 
Colon Cancer Metastatic  1  0/300 (0.00%)  1/302 (0.33%) 
Gallbladder Cancer  1  1/300 (0.33%)  0/302 (0.00%) 
Gammopathy  1  0/300 (0.00%)  1/302 (0.33%) 
Gastric Cancer  1  1/300 (0.33%)  0/302 (0.00%) 
Laryngeal Cancer  1  1/300 (0.33%)  0/302 (0.00%) 
Malignant Melanoma  1  1/300 (0.33%)  0/302 (0.00%) 
Metastases To Liver  1  1/300 (0.33%)  0/302 (0.00%) 
Metastatic Neoplasm  1  1/300 (0.33%)  0/302 (0.00%) 
Ovarian Adenoma  1  0/300 (0.00%)  1/302 (0.33%) 
Pancreatic Neoplasm  1  0/300 (0.00%)  1/302 (0.33%) 
Parathyroid Tumour  1  0/300 (0.00%)  1/302 (0.33%) 
Prostatic Adenoma  1  0/300 (0.00%)  1/302 (0.33%) 
Tongue Neoplasm Malignant Stage Unspecified  1  0/300 (0.00%)  1/302 (0.33%) 
Nervous system disorders     
Cerebrovascular Accident  1  7/300 (2.33%)  5/302 (1.66%) 
Syncope  1  1/300 (0.33%)  3/302 (0.99%) 
Headache  1  2/300 (0.67%)  1/302 (0.33%) 
Diabetic Neuropathy  1  2/300 (0.67%)  0/302 (0.00%) 
Dizziness  1  1/300 (0.33%)  1/302 (0.33%) 
Transient Ischaemic Attack  1  2/300 (0.67%)  0/302 (0.00%) 
Carotid Artery Stenosis  1  0/300 (0.00%)  1/302 (0.33%) 
Carpal Tunnel Syndrome  1  1/300 (0.33%)  0/302 (0.00%) 
Cervical Root Pain  1  0/300 (0.00%)  1/302 (0.33%) 
Cervicobrachial Syndrome  1  0/300 (0.00%)  1/302 (0.33%) 
Dementia Alzheimer's Type  1  0/300 (0.00%)  1/302 (0.33%) 
Diabetic Hyperglycaemic Coma  1  1/300 (0.33%)  0/302 (0.00%) 
Disturbance In Attention  1  1/300 (0.33%)  0/302 (0.00%) 
Dizziness Postural  1  0/300 (0.00%)  1/302 (0.33%) 
Hypersomnia  1  1/300 (0.33%)  0/302 (0.00%) 
Hypertonia  1  1/300 (0.33%)  0/302 (0.00%) 
Loss Of Consciousness  1  0/300 (0.00%)  1/302 (0.33%) 
Neuralgia  1  0/300 (0.00%)  1/302 (0.33%) 
Uraemic Encephalopathy  1  1/300 (0.33%)  0/302 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  2/300 (0.67%)  1/302 (0.33%) 
Premature Labour  1  1/300 (0.33%)  0/302 (0.00%) 
Psychiatric disorders     
Confusional State  1  2/300 (0.67%)  0/302 (0.00%) 
Amnestic Disorder  1  1/300 (0.33%)  0/302 (0.00%) 
Disorientation  1  1/300 (0.33%)  0/302 (0.00%) 
Renal and urinary disorders     
Renal Failure  1  17/300 (5.67%)  12/302 (3.97%) 
Renal Impairment  1  5/300 (1.67%)  9/302 (2.98%) 
Renal Failure Chronic  1  7/300 (2.33%)  6/302 (1.99%) 
Azotaemia  1  5/300 (1.67%)  1/302 (0.33%) 
Haematuria  1  4/300 (1.33%)  1/302 (0.33%) 
Urinary Retention  1  1/300 (0.33%)  3/302 (0.99%) 
Hydronephrosis  1  0/300 (0.00%)  2/302 (0.66%) 
Renal Cyst Ruptured  1  1/300 (0.33%)  1/302 (0.33%) 
Renal Failure Acute  1  1/300 (0.33%)  1/302 (0.33%) 
Renal Haemorrhage  1  1/300 (0.33%)  1/302 (0.33%) 
Calculus Ureteric  1  1/300 (0.33%)  0/302 (0.00%) 
Glomerulonephritis  1  0/300 (0.00%)  1/302 (0.33%) 
Haemorrhage Urinary Tract  1  1/300 (0.33%)  0/302 (0.00%) 
Hypertensive Nephropathy  1  0/300 (0.00%)  1/302 (0.33%) 
Nephritis Interstitial  1  1/300 (0.33%)  0/302 (0.00%) 
Nephrolithiasis  1  0/300 (0.00%)  1/302 (0.33%) 
Renal Artery Stenosis  1  0/300 (0.00%)  1/302 (0.33%) 
Urinary Bladder Polyp  1  1/300 (0.33%)  0/302 (0.00%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1  1/300 (0.33%)  0/302 (0.00%) 
Epididymitis  1  1/300 (0.33%)  0/302 (0.00%) 
Ovarian Cyst  1  0/300 (0.00%)  1/302 (0.33%) 
Prostatitis  1  1/300 (0.33%)  0/302 (0.00%) 
Uterine Prolapse  1  0/300 (0.00%)  1/302 (0.33%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/300 (0.67%)  3/302 (0.99%) 
Pulmonary Embolism  1  3/300 (1.00%)  1/302 (0.33%) 
Pleural Effusion  1  1/300 (0.33%)  2/302 (0.66%) 
Respiratory Failure  1  1/300 (0.33%)  2/302 (0.66%) 
Lung Disorder  1  2/300 (0.67%)  0/302 (0.00%) 
Chronic Obstructive Airways Disease  1  1/300 (0.33%)  0/302 (0.00%) 
Epistaxis  1  1/300 (0.33%)  0/302 (0.00%) 
Haemoptysis  1  1/300 (0.33%)  0/302 (0.00%) 
Hypercapnia  1  0/300 (0.00%)  1/302 (0.33%) 
Laryngeal Dysplasia  1  1/300 (0.33%)  0/302 (0.00%) 
Vocal Cord Polyp  1  1/300 (0.33%)  0/302 (0.00%) 
Pulmonary Oedema  1  0/300 (0.00%)  1/302 (0.33%) 
Skin and subcutaneous tissue disorders     
Skin Ulcer  1  0/300 (0.00%)  3/302 (0.99%) 
Angioneurotic Oedema  1  1/300 (0.33%)  0/302 (0.00%) 
Urticaria  1  1/300 (0.33%)  0/302 (0.00%) 
Surgical and medical procedures     
Nephrectomy  1  2/300 (0.67%)  1/302 (0.33%) 
Insertion Of Ambulatory Peritoneal Catheter  1  1/300 (0.33%)  1/302 (0.33%) 
Arteriovenous Fistula Operation  1  0/300 (0.00%)  1/302 (0.33%) 
Cataract Operation  1  0/300 (0.00%)  1/302 (0.33%) 
Catheter Placement  1  1/300 (0.33%)  0/302 (0.00%) 
Eye Operation  1  1/300 (0.33%)  0/302 (0.00%) 
Knee Arthroplasty  1  1/300 (0.33%)  0/302 (0.00%) 
Peritoneal Dialysis  1  1/300 (0.33%)  0/302 (0.00%) 
Rehabilitation Therapy  1  1/300 (0.33%)  0/302 (0.00%) 
Renal Transplant  1  1/300 (0.33%)  0/302 (0.00%) 
Vascular disorders     
Peripheral Vascular Disorder  1  12/300 (4.00%)  7/302 (2.32%) 
Hypotension  1  2/300 (0.67%)  2/302 (0.66%) 
Deep Vein Thrombosis  1  1/300 (0.33%)  2/302 (0.66%) 
Arterial Stenosis  1  2/300 (0.67%)  0/302 (0.00%) 
Hypertension  1  0/300 (0.00%)  2/302 (0.66%) 
Hypertensive Crisis  1  2/300 (0.67%)  0/302 (0.00%) 
Lymphocele  1  1/300 (0.33%)  1/302 (0.33%) 
Phlebitis  1  2/300 (0.67%)  0/302 (0.00%) 
Aneurysm Arteriovenous  1  1/300 (0.33%)  0/302 (0.00%) 
Aortic Aneurysm  1  1/300 (0.33%)  0/302 (0.00%) 
Arteriosclerosis  1  0/300 (0.00%)  1/302 (0.33%) 
Arteriovenous Fistula, Acquired  1  0/300 (0.00%)  1/302 (0.33%) 
Circulatory Collapse  1  1/300 (0.33%)  0/302 (0.00%) 
Malignant Hypertension  1  1/300 (0.33%)  0/302 (0.00%) 
Orthostatic Hypotension  1  1/300 (0.33%)  0/302 (0.00%) 
Subclavian Artery Aneurysm  1  1/300 (0.33%)  0/302 (0.00%) 
Thrombophlebitis  1  1/300 (0.33%)  0/302 (0.00%) 
Venous Thrombosis Limb  1  0/300 (0.00%)  1/302 (0.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Epoetin Beta Therapy Late Epoetin Beta Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   243/300 (81.00%)   228/302 (75.50%) 
Gastrointestinal disorders     
Diarrhoea  1  24/300 (8.00%)  25/302 (8.28%) 
Constipation  1  22/300 (7.33%)  19/302 (6.29%) 
Nausea  1  15/300 (5.00%)  14/302 (4.64%) 
Vomiting  1  15/300 (5.00%)  12/302 (3.97%) 
General disorders     
Oedema Peripheral  1  20/300 (6.67%)  11/302 (3.64%) 
Asthenia  1  16/300 (5.33%)  17/302 (5.63%) 
Fatigue  1  14/300 (4.67%)  17/302 (5.63%) 
Infections and infestations     
Upper respiratory tract infection  1  16/300 (5.33%)  28/302 (9.27%) 
Urinary tract infection  1  26/300 (8.67%)  29/302 (9.60%) 
Nasopharyngitis  1  24/300 (8.00%)  23/302 (7.62%) 
Influenza  1  26/300 (8.67%)  12/302 (3.97%) 
Bronchitis  1  12/300 (4.00%)  16/302 (5.30%) 
Bronchitis Acute  1  15/300 (5.00%)  6/302 (1.99%) 
Investigations     
Blood Pressure Increased  1  19/300 (6.33%)  13/302 (4.30%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  28/300 (9.33%)  30/302 (9.93%) 
Hyperphosphataemia  1  27/300 (9.00%)  22/302 (7.28%) 
Gout  1  15/300 (5.00%)  16/302 (5.30%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  22/300 (7.33%)  33/302 (10.93%) 
Arthralgia  1  21/300 (7.00%)  19/302 (6.29%) 
Pain in extremity  1  18/300 (6.00%)  16/302 (5.30%) 
Muscle cramp  1  9/300 (3.00%)  16/302 (5.30%) 
Nervous system disorders     
Headache  1  30/300 (10.00%)  15/302 (4.97%) 
Dizziness  1  18/300 (6.00%)  13/302 (4.30%) 
Psychiatric disorders     
Insomnia  1  12/300 (4.00%)  23/302 (7.62%) 
Renal and urinary disorders     
Renal Failure  1  93/300 (31.00%)  87/302 (28.81%) 
Renal Failure Chronic  1  33/300 (11.00%)  46/302 (15.23%) 
Renal Impairment  1  27/300 (9.00%)  23/302 (7.62%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  20/300 (6.67%)  16/302 (5.30%) 
Skin and subcutaneous tissue disorders     
Pruritis  1  27/300 (9.00%)  18/302 (5.96%) 
Vascular disorders     
Hypertension  1  89/300 (29.67%)  58/302 (19.21%) 
Hypotension  1  13/300 (4.33%)  16/302 (5.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00321919    
Other Study ID Numbers: BA16169
First Submitted: May 3, 2006
First Posted: May 4, 2006
Results First Submitted: February 24, 2016
Results First Posted: May 25, 2016
Last Update Posted: June 29, 2016