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A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT00077610
Recruitment Status : Completed
First Posted : February 13, 2004
Results First Posted : February 29, 2016
Last Update Posted : January 13, 2017
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
Interventions Drug: Epoetin alfa or beta
Drug: RO0503821 (1x/2 Weeks)
Drug: RO0503821 (1x/4 Weeks)
Enrollment 673
Recruitment Details A total of 673 participants were recruited at 91 centers in 8 countries with chronic renal anemia and dialysis therapy for at least 12 weeks before screening and during the screening/baseline period. This study was conducted between February 25, 2004 and August 17, 2005
Pre-assignment Details  
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug. Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug. Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Period Title: Overall Study
Started 223 224 226
Started Treatment 221 220 225
Completed 169 168 180
Not Completed 54 56 46
Reason Not Completed
Adverse Event             9             7             1
Lost to Follow-up             0             1             2
Withdrawal by Subject             4             10             6
Death             17             13             13
Renal transplant             12             15             11
Withdrew from dialysis care             5             0             3
Insufficient Therapeutic Response             1             0             0
Multiple blood transfusions             0             0             1
Principal Investigator's decision             1             0             1
Worsening of health condition             1             1             0
Given Epogen in hospital             1             0             0
Transferred to other unit             0             0             1
Transferred to nursing home             0             0             1
Transfer to satellite unit             1             0             0
Transfer to other center for surgery             1             0             0
Change in dialysis modality             1             0             0
Relocation             0             8             5
Financial issues             0             1             0
Sponsors decision to withdraw             0             0             1
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks) Total
Hide Arm/Group Description Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug. Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug. Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 221 220 225 666
Hide Baseline Analysis Population Description
The safety population included all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 221 participants 220 participants 225 participants 666 participants
59.2  (15.05) 59.0  (15.00) 58.5  (15.16) 58.9  (15.05)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 220 participants 225 participants 666 participants
Female
89
  40.3%
95
  43.2%
92
  40.9%
276
  41.4%
Male
132
  59.7%
125
  56.8%
133
  59.1%
390
  58.6%
1.Primary Outcome
Title Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period
Hide Description A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.
Time Frame Baseline, Week 29 to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to Hb parameters and <5 recorded Hb values during the evaluation period with missing administrations of the study drug/ reference drug. Please refer to the outcome measure description section for more details.
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Week)
Hide Arm/Group Description:
Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 120,180 mcg) that was based on the Epoetin dose administered (<8000, 8000-16000, >16000 IU/Week) during the week preceding the switch to the study drug.
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Number of Participants Analyzed 188 172 180
Mean (Standard Deviation)
Unit of Measure: gram per deciliter (g/dL)
-0.10  (1.06) 0.01  (0.96) -0.10  (0.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RO0503821 (1x/2 Weeks), Epoetin (1-3x/Week)
Comments The non-inferiority test for treatment differences in Hb change from baseline, based on analysis of co-variance (ANCOVA) analysis with a non-inferiority limit of -0.75 g/dL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to –0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA, CI for difference between groups
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference between groups
Estimated Value 0.004
Confidence Interval (2-Sided) 97.5%
-0.215 to 0.223
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0973
Estimation Comments Difference between groups based on the adjusted means derived from the ANCOVA model
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RO0503821 (1x/4 Weeks), Epoetin (1-3x/Week)
Comments The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.3 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA, CI for difference between groups
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference between groups
Estimated Value 0.051
Confidence Interval (2-Sided) 97.5%
-0.173 to 0.275
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0997
Estimation Comments Difference between groups based on the adjusted means derived from the ANCOVA model
2.Secondary Outcome
Title Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.
Hide Description The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.
Time Frame Baseline, Week 29 to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was defined as all randomized participants. At the end of Week 36, data allowing the evaluation of the therapeutic response was available for 196/221, 188/220, and 205/225 participants in RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks), and Epoetin (1 -3x/Weeks), respectively.
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description:
Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Number of Participants Analyzed 196 188 205
Measure Type: Number
Unit of Measure: participants
133 127 138
3.Secondary Outcome
Title The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
Hide Description The number of participants who received RBC transfusions during the titration and evaluation periods were reported .
Time Frame Week 1 to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not.
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description:
Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks
Overall Number of Participants Analyzed 221 220 225
Measure Type: Number
Unit of Measure: participants
21 16 17
4.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)
Hide Description Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L.
Time Frame Up to Week 53
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description:
Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Number of Participants Analyzed 218 217 223
Measure Type: Number
Unit of Measure: participants
High Platelet (n=218, 216, 223) 0 1 3
Low Platelet (n=218, 216, 223) 14 10 6
High WBC (n=218, 217, 223) 0 2 3
Low WBC (n=218, 217, 223) 8 6 5
High RBC (n=124, 129, 89) 1 2 0
Low RBC (n=124, 129, 89) 1 2 0
5.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes
Hide Description Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L
Time Frame Up to Week 53
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description:
Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Number of Participants Analyzed 218 216 224
Measure Type: Number
Unit of Measure: participants
High ALT. (n=218, 216, 224) 4 2 5
High ALP (n=218, 216, 224) 15 14 16
Low Albumin (n=218, 216, 224) 14 13 18
High Phosphate (n=218, 216, 224) 106 95 94
Low Phosphate (n=218, 216, 224) 21 21 17
High Potassium (n=218, 216, 224) 33 35 36
Low Potassium (n=218, 216, 224) 10 3 3
High AST (n=218, 215, 224) 6 3 4
High Blood glucose in non-diabetic (n=114,131,110) 0 3 1
Low Blood Glucose in Non-Diabetic (n=114,131,110) 0 1 0
6.Secondary Outcome
Title Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
Hide Description Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).
Time Frame Baseline, Week 36 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description:
Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Number of Participants Analyzed 189 178 196
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Change in SBP, BD at Wk 36 (n=189, 178,196) 1  (25.3) -2  (22.7) 3  (25.1)
Change in SBP, BD at Wk 52 (n=168, 166, 180) -0  (24.6) -3  (24.6) 1  (26.0)
Change in DBP, BD at Wk 36 (n=189, 178, 195) 0  (14.7) -3  (16.3) 1  (16.8)
Change in DBP, BD at Wk 52 (n=168, 166, 179) 1  (15.2) -3  (18.3) -1  (15.4)
Change in SBP, AD at Wk 36 (n=189, 177, 196) 3  (28.3) -1  (27.0) -0  (24.3)
Change in SBP, AD at Wk 52 (n=167, 168, 179) 2  (24.5) -0  (29.3) 1  (24.9)
Change in DBP, AD at Wk 36 (n=189, 177, 196) -1  (16.4) -0  (15.2) -2  (12.4)
Change in DBP, AD at Wk 52 (n=167, 168, 178) -1  (14.9) -0  (15.9) -3  (14.9)
7.Secondary Outcome
Title Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
Hide Description Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline value and a value for specified time period.
Time Frame Baseline, Week 36 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description:
Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Number of Participants Analyzed 188 176 193
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Change from BL at Week 36 (n=188, 176, 193) 1  (12.0) 2  (11.8) 0  (14.5)
Change from BL at Week 52 (n=168, 166, 179) 1  (13.6) 1  (13.4) -1  (13.2)
8.Secondary Outcome
Title Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
Hide Description An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.
Time Frame Upto Week 53
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description:
Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose administered during the week preceding the switch to the study drug.
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Number of Participants Analyzed 221 220 225
Measure Type: Number
Unit of Measure: participants
Number of participants with adverse events 203 202 214
Number of participants with serious adverse events 101 87 99
Number of deaths 19 15 17
Time Frame Up to Week 53
Adverse Event Reporting Description Of 673 recruited participants, 7 withdrew before receiving the study drug (2 in the RO0503821 [1x/2 Weeks], 4 in the RO0503821 [1x/4 Weeks] and 1 from Epoetin group). The safety population included all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not.
 
Arm/Group Title RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Hide Arm/Group Description Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug. Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug. Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
All-Cause Mortality
RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   101/221 (45.70%)   87/220 (39.55%)   99/225 (44.00%) 
Blood and lymphatic system disorders       
Anaemia  1  0/221 (0.00%)  0/220 (0.00%)  2/225 (0.89%) 
Haemolysis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Leukocytosis  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Cardiac disorders       
Cardiac failure congestive  1  6/221 (2.71%)  3/220 (1.36%)  7/225 (3.11%) 
Myocardial infarction  1  3/221 (1.36%)  3/220 (1.36%)  7/225 (3.11%) 
Cardiac arrest  1  8/221 (3.62%)  2/220 (0.91%)  2/225 (0.89%) 
Cardio respiratory arrest  1  3/221 (1.36%)  2/220 (0.91%)  3/225 (1.33%) 
Acute myocardial infarction  1  3/221 (1.36%)  2/220 (0.91%)  2/225 (0.89%) 
Atrial fibrillation  1  1/221 (0.45%)  4/220 (1.82%)  1/225 (0.44%) 
Coronary artery disease  1  3/221 (1.36%)  0/220 (0.00%)  3/225 (1.33%) 
Aortic valve stenosis  1  1/221 (0.45%)  3/220 (1.36%)  1/225 (0.44%) 
Acute coronary syndrome  1  1/221 (0.45%)  0/220 (0.00%)  2/225 (0.89%) 
Angina pectoris  1  1/221 (0.45%)  1/220 (0.45%)  1/225 (0.44%) 
Atrial flutter  1  1/221 (0.45%)  0/220 (0.00%)  2/225 (0.89%) 
Angina unstable  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Bradycardia  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Cardiogenic shock  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Ventricular tachycardia  1  1/221 (0.45%)  0/220 (0.00%)  1/225 (0.44%) 
Aortic valve calcification  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Arrhythmia  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Atrial tachycardia  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Atrioventricular block complete  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Cardiac failure  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Congestive cardiomyopathy  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Coronary artery stenosis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Palpitations  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Pericardial effusion  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Right ventricular failure  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Tachycardia  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Congenital, familial and genetic disorders       
Congenital cystic kidney disease  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Gastrointestinal angiodysplasia  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Ear and labyrinth disorders       
Cerumen impaction  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Vestibular neuronitis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Endocrine disorders       
Intestinal infarction  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Hyperparathyroidism  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Eye disorders       
Angle closure glaucoma  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Blindness transient  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Glaucoma  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Retinal haemorrhage  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage  1  2/221 (0.90%)  2/220 (0.91%)  0/225 (0.00%) 
Diabetic gastroparesis  1  1/221 (0.45%)  1/220 (0.45%)  1/225 (0.44%) 
Diarrhoea  1  2/221 (0.90%)  1/220 (0.45%)  0/225 (0.00%) 
Gastric ulcer haemorrhage  1  2/221 (0.90%)  1/220 (0.45%)  0/225 (0.00%) 
Pancreatitis  1  2/221 (0.90%)  0/220 (0.00%)  1/225 (0.44%) 
Small intestinal obstruction  1  2/221 (0.90%)  0/220 (0.00%)  1/225 (0.44%) 
Abdominal pain  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Colitis ischaemic  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Impaired gastric emptying  1  0/221 (0.00%)  1/220 (0.45%)  1/225 (0.44%) 
Upper gastrointestinal haemorrhage  1  0/221 (0.00%)  2/220 (0.91%)  0/225 (0.00%) 
Abdominal hernia  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Abdominal pain upper  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Anal fissure  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Colitis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Dysphagia  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Food poisoning  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Gastric ulcer  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Gastric ulcer perforation  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Gastritis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Gastritis erosive  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Gastritis haemorrhagic  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Haematemesis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Haemorrhoidal haemorrhage  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Intestinal dilatation  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Intestinal ischaemia  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Intestinal obstruction  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Large intestine perforation  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Mallory-Weiss syndrome  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Oesophagitis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Pancreatitis acute  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Vomiting  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
General disorders       
Chest pain  1  1/221 (0.45%)  2/220 (0.91%)  7/225 (3.11%) 
Non-cardiac chest pain  1  2/221 (0.90%)  1/220 (0.45%)  2/225 (0.89%) 
Multi-organ failure  1  0/221 (0.00%)  0/220 (0.00%)  2/225 (0.89%) 
Pyrexia  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Sudden death  1  0/221 (0.00%)  2/220 (0.91%)  0/225 (0.00%) 
Catheter related complication  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Catheter site haemorrhage  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Hyperpyrexia  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Hypothermia  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Influenza like illness  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Sudden cardiac death  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/221 (0.00%)  0/220 (0.00%)  2/225 (0.89%) 
Cholelithiasis  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Gallbladder polyp  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Hepatic cirrhosis  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Hepatitis acute  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Immune system disorders       
Drug hypersensitivity  1  1/221 (0.45%)  0/220 (0.00%)  1/225 (0.44%) 
Hypersensitivity  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Kidney transplant rejection  1  0/221 (0.00%)  2/220 (0.91%)  0/225 (0.00%) 
Infections and infestations       
Sepsis  1  5/221 (2.26%)  6/220 (2.73%)  9/225 (4.00%) 
Pneumonia  1  9/221 (4.07%)  5/220 (2.27%)  5/225 (2.22%) 
Cellulitis  1  3/221 (1.36%)  1/220 (0.45%)  4/225 (1.78%) 
Arteriovenous graft site infection  1  1/221 (0.45%)  3/220 (1.36%)  2/225 (0.89%) 
Staphylococcal bacteraemia  1  2/221 (0.90%)  3/220 (1.36%)  1/225 (0.44%) 
Gangrene  1  1/221 (0.45%)  0/220 (0.00%)  3/225 (1.33%) 
Septic shock  1  0/221 (0.00%)  2/220 (0.91%)  2/225 (0.89%) 
Staphylococcal sepsis  1  2/221 (0.90%)  1/220 (0.45%)  1/225 (0.44%) 
Bacteraemia  1  1/221 (0.45%)  0/220 (0.00%)  2/225 (0.89%) 
Urosepsis  1  0/221 (0.00%)  3/220 (1.36%)  0/225 (0.00%) 
Catheter sepsis  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Clostridium colitis  1  2/221 (0.90%)  0/220 (0.00%)  0/225 (0.00%) 
Diverticulitis  1  0/221 (0.00%)  0/220 (0.00%)  2/225 (0.89%) 
Gastroenteritis viral  1  0/221 (0.00%)  1/220 (0.45%)  1/225 (0.44%) 
Lobar pneumonia  1  2/221 (0.90%)  0/220 (0.00%)  0/225 (0.00%) 
Urinary tract infection  1  0/221 (0.00%)  2/220 (0.91%)  0/225 (0.00%) 
Viral upper respiratory tract infection  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Abdominal abscess  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Arteriovenous graft site abscess  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Biliary sepsis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Bronchitis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Bronchitis acute viral  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Catheter related infection  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Endocarditis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Escherichia infection  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Gastroenteritis  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Groin abscess  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Infection  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Influenza  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Necrotising fasciitis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Osteomyelitis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Pneumococcal sepsis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Pneumonia staphylococcal  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Postoperative infection  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Postoperative wound infection  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Pulmonary sepsis  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Pyelonephritis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Sepsis syndrome  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Splenic abscess  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Staphylococcal osteomyelitis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Injury, poisoning and procedural complications       
Arteriovenous graft thrombosis  1  2/221 (0.90%)  8/220 (3.64%)  7/225 (3.11%) 
Arteriovenous fistula thrombosis  1  2/221 (0.90%)  4/220 (1.82%)  4/225 (1.78%) 
Ankle fracture  1  0/221 (0.00%)  1/220 (0.45%)  2/225 (0.89%) 
Arteriovenous graft site haemorrhage  1  2/221 (0.90%)  1/220 (0.45%)  0/225 (0.00%) 
Femur fracture  1  1/221 (0.45%)  1/220 (0.45%)  1/225 (0.44%) 
Vascular graft complication  1  2/221 (0.90%)  1/220 (0.45%)  0/225 (0.00%) 
Arteriovenous fistula site complication  1  0/221 (0.00%)  1/220 (0.45%)  1/225 (0.44%) 
Femoral neck fracture  1  0/221 (0.00%)  1/220 (0.45%)  1/225 (0.44%) 
Hip fracture  1  2/221 (0.90%)  0/220 (0.00%)  0/225 (0.00%) 
Spinal compression fracture  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Arteriovenous fistula site haemorrhage  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Chest injury  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Fall  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Forearm fracture  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Fractured sacrum  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Head injury  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Lumbar vertebral fracture  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Operative haemorrhage  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Post procedural haemorrhage  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Procedural hypotension  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Spinal fracture  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Tibia fracture  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Traumatic intracranial haemorrhage  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Vascular access complication  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Vascular graft occlusion  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Wound evisceration  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Metabolism and nutrition disorders       
Fluid overload  1  5/221 (2.26%)  4/220 (1.82%)  4/225 (1.78%) 
Hyperkalaemia  1  2/221 (0.90%)  1/220 (0.45%)  5/225 (2.22%) 
Hypoglycaemia  1  2/221 (0.90%)  2/220 (0.91%)  3/225 (1.33%) 
Dehydration  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Diabetic ketoacidosis  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Hypovolaemia  1  0/221 (0.00%)  1/220 (0.45%)  1/225 (0.44%) 
Failure to thrive  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Hyperglycaemia  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain  1  2/221 (0.90%)  0/220 (0.00%)  1/225 (0.44%) 
Spinal column stenosis  1  0/221 (0.00%)  2/220 (0.91%)  1/225 (0.44%) 
Intervertebral discitis  1  0/221 (0.00%)  1/220 (0.45%)  1/225 (0.44%) 
Rhabdomyolysis  1  0/221 (0.00%)  1/220 (0.45%)  1/225 (0.44%) 
Shoulder pain  1  2/221 (0.90%)  0/220 (0.00%)  0/225 (0.00%) 
Arthralgia  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Arthritis  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Back pain  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Bursa disorder  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Fracture nonunion  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Muscular weakness  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Musculoskeletal pain  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Myalgia  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Osteonecrosis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Spinal osteoarthritis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anal cancer  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Colon cancer  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Endometrial cancer  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Essential thrombocythaemia  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Lung adenocarcinoma  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Lung adenocarcinoma metastatic  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Metastases to bone  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Myelodysplastic syndrome  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Myelofibrosis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Neoplasm  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Non-Hodgkin’s lymphoma  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Prostate cancer  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Prostate cancer metastatic  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Renal cancer metastatic  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Renal neoplasm  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Nervous system disorders       
Syncope  1  1/221 (0.45%)  2/220 (0.91%)  2/225 (0.89%) 
Transient ischaemic attack  1  2/221 (0.90%)  1/220 (0.45%)  1/225 (0.44%) 
Cerebral thrombosis  1  0/221 (0.00%)  3/220 (1.36%)  0/225 (0.00%) 
Dementia  1  1/221 (0.45%)  0/220 (0.00%)  1/225 (0.44%) 
Benign intracranial hypertension  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Brain stem infarction  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Carotid artery stenosis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Carpal tunnel syndrome  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Cerebral haemorrhage  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Cerebral infarction  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Cerebrovascular accident  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Complex partial seizures  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Depressed level of consciousness  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Dizziness  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Grand mal convulsion  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Haemorrhage intracranial  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Hepatic encephalopathy  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Hypertensive encephalopathy  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Migraine  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Nervous system disorder  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Subarachnoid haemorrhage  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Syncope vasovagal  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Thrombotic stroke  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Haematoma  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Psychiatric disorders       
Mental status changes  1  2/221 (0.90%)  1/220 (0.45%)  1/225 (0.44%) 
Confusional state  1  1/221 (0.45%)  1/220 (0.45%)  1/225 (0.44%) 
Hypomania  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Renal and urinary disorders       
Renal failure chronic  1  4/221 (1.81%)  1/220 (0.45%)  7/225 (3.11%) 
Haematuria  1  2/221 (0.90%)  0/220 (0.00%)  0/225 (0.00%) 
Renal disorder  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Renal failure  1  1/221 (0.45%)  0/220 (0.00%)  1/225 (0.44%) 
Nephrolithiasis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Renal haemorrhage  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Reproductive system and breast disorders       
Female genital-digestive tract fistula  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Ovarian cyst  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Testicular pain  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory failure  1  0/221 (0.00%)  3/220 (1.36%)  2/225 (0.89%) 
Chronic obstructive pulmonary disease  1  2/221 (0.90%)  1/220 (0.45%)  0/225 (0.00%) 
Dyspnoea  1  2/221 (0.90%)  0/220 (0.00%)  1/225 (0.44%) 
Pulmonary oedema  1  3/221 (1.36%)  0/220 (0.00%)  0/225 (0.00%) 
Acute pulmonary oedema  1  1/221 (0.45%)  0/220 (0.00%)  1/225 (0.44%) 
Pulmonary embolism  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Acute respiratory failure  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Asthma  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Bronchospasm  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Pulmonary haemorrhage  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Vocal cord polyp  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin ulcer  1  1/221 (0.45%)  0/220 (0.00%)  2/225 (0.89%) 
Decubitus ulcer  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Diabetic dermopathy  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Diabetic ulcer  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Skin necrosis  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Toxic epidermal necrolysis  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  0/221 (0.00%)  2/220 (0.91%)  2/225 (0.89%) 
Hypertensive crisis  1  1/221 (0.45%)  1/220 (0.45%)  2/225 (0.89%) 
Peripheral ischaemia  1  0/221 (0.00%)  3/220 (1.36%)  1/225 (0.44%) 
Hypertension  1  1/221 (0.45%)  1/220 (0.45%)  1/225 (0.44%) 
Hypotension  1  1/221 (0.45%)  1/220 (0.45%)  0/225 (0.00%) 
Venous stenosis  1  1/221 (0.45%)  0/220 (0.00%)  1/225 (0.44%) 
Air embolism  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Aneurysm arteriovenous  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Aortic aneurysm  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Arterial haemorrhage  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Arteriovenous fistula  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Diabetic vascular disorder  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Extremity necrosis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Hypoperfusion  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Peripheral artery aneurysm  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Peripheral vascular disorder  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Subclavian vein thrombosis  1  1/221 (0.45%)  0/220 (0.00%)  0/225 (0.00%) 
Thrombosis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Vascular pseudoaneurysm  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Venous thrombosis  1  0/221 (0.00%)  0/220 (0.00%)  1/225 (0.44%) 
Venous thrombosis limb  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Wound haemorrhage  1  0/221 (0.00%)  1/220 (0.45%)  0/225 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RO0503821 (1x/2 Weeks) RO0503821 (1x/4 Weeks) Epoetin (1-3x/Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   166/221 (75.11%)   151/220 (68.64%)   175/225 (77.78%) 
Gastrointestinal disorders       
Diarrhoea  1  37/221 (16.74%)  25/220 (11.36%)  30/225 (13.33%) 
Vomiting  1  16/221 (7.24%)  11/220 (5.00%)  14/225 (6.22%) 
Nausea  1  10/221 (4.52%)  9/220 (4.09%)  15/225 (6.67%) 
Constipation  1  12/221 (5.43%)  4/220 (1.82%)  12/225 (5.33%) 
General disorders       
Pyrexia  1  8/221 (3.62%)  8/220 (3.64%)  17/225 (7.56%) 
Asthenia  1  11/221 (4.98%)  15/220 (6.82%)  6/225 (2.67%) 
Fatigue  1  12/221 (5.43%)  9/220 (4.09%)  6/225 (2.67%) 
Infections and infestations       
Nasopharyngitis  1  28/221 (12.67%)  39/220 (17.73%)  24/225 (10.67%) 
Upper respiratory tract infection  1  20/221 (9.05%)  30/220 (13.64%)  25/225 (11.11%) 
Urinary tract infection  1  13/221 (5.88%)  12/220 (5.45%)  9/225 (4.00%) 
Gastroenteritis  1  6/221 (2.71%)  11/220 (5.00%)  3/225 (1.33%) 
Injury, poisoning and procedural complications       
Arteriovenous graft thrombosis  1  24/221 (10.86%)  23/220 (10.45%)  28/225 (12.44%) 
Fall  1  15/221 (6.79%)  19/220 (8.64%)  15/225 (6.67%) 
Procedural hypotension  1  18/221 (8.14%)  20/220 (9.09%)  9/225 (4.00%) 
Arteriovenous fistula site complication  1  16/221 (7.24%)  10/220 (4.55%)  15/225 (6.67%) 
Vascular graft complication  1  8/221 (3.62%)  13/220 (5.91%)  13/225 (5.78%) 
Arteriovenous fistula thrombosis  1  9/221 (4.07%)  8/220 (3.64%)  15/225 (6.67%) 
Arteriovenous fistula site haemorrhage  1  12/221 (5.43%)  7/220 (3.18%)  4/225 (1.78%) 
Metabolism and nutrition disorders       
Fluid overload  1  23/221 (10.41%)  18/220 (8.18%)  13/225 (5.78%) 
Musculoskeletal and connective tissue disorders       
Muscle spasms  1  19/221 (8.60%)  19/220 (8.64%)  24/225 (10.67%) 
Pain in extremity  1  19/221 (8.60%)  11/220 (5.00%)  18/225 (8.00%) 
Back pain  1  19/221 (8.60%)  15/220 (6.82%)  12/225 (5.33%) 
Arthralgia  1  11/221 (4.98%)  3/220 (1.36%)  12/225 (5.33%) 
Nervous system disorders       
Headache  1  30/221 (13.57%)  17/220 (7.73%)  24/225 (10.67%) 
Dizziness  1  6/221 (2.71%)  13/220 (5.91%)  12/225 (5.33%) 
Psychiatric disorders       
Insomnia  1  11/221 (4.98%)  14/220 (6.36%)  14/225 (6.22%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  20/221 (9.05%)  19/220 (8.64%)  18/225 (8.00%) 
Dyspnoea  1  8/221 (3.62%)  9/220 (4.09%)  15/225 (6.67%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  11/221 (4.98%)  11/220 (5.00%)  14/225 (6.22%) 
Vascular disorders       
Hypertension  1  22/221 (9.95%)  28/220 (12.73%)  34/225 (15.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Ver 8.1
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
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077610     History of Changes
Other Study ID Numbers: BA16739
First Submitted: February 10, 2004
First Posted: February 13, 2004
Results First Submitted: January 29, 2016
Results First Posted: February 29, 2016
Last Update Posted: January 13, 2017