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A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00090753
Collaborator
(none)
1,228
Enrollment
249
Locations
2
Arms
62
Duration (Months)
4.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

Condition or Disease Intervention/Treatment Phase
  • Drug: Methoxy Polyethylene Glycol-Epoetin Beta
  • Drug: Epoetin alfa
  • Drug: Epoetin beta
  • Drug: Darbepoetin alfa
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1228 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methoxy Polyethylene Glycol-Epoetin Beta

Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.

Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.
Other Names:
  • RO0503821
  • Mircera

    		•
    Active Comparator: Comparator ESA

    Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.

    Drug: Epoetin alfa
    Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).

    Drug: Epoetin beta
    Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).

    Drug: Darbepoetin alfa
    Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation [Baseline to the end of the study (Up to 49 Months)]

      Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.

    Secondary Outcome Measures

    1. Percentage of Patients Who Had at Least 1 Adverse Event [From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)]

      See the adverse events section of the results for more information.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written informed consent

    • Adult patients (≥ 18 years old) with chronic renal anemia

    • Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]

    • Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL

    • Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) < 10%

    Exclusion Criteria:

    • Poorly controlled hypertension

    • History of epileptic seizure

    • Pure red cell aplasia

    • Chronic congestive heart failure [New York Heart Association (NYHA) IV]

    • High likelihood of early withdrawal or interruption of the study

    • Active malignant disease (except non-melanoma skin cancer)

    • Life expectancy less than 12 months

    • Pregnancy or breast-feeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35211
    2 Mobile Alabama United States 36608
    3 Montgomery Alabama United States 36106
    4 Hot Springs Arkansas United States 71901
    5 Covina California United States 91723
    6 Encino California United States 91356
    7 Irvine California United States 92868
    8 Los Alamitos California United States 90720
    9 Los Angeles California United States 90073
    10 Los Angeles California United States 90095
    11 Monterey Park California United States 91754
    12 Mountain View California United States 94040
    13 Sacramento California United States 95816-5119
    14 San Diego California United States 92120
    15 San Diego California United States 92123
    16 San Francisco California United States 94117
    17 Stanford California United States 94305
    18 Colorado Springs Colorado United States 80909
    19 Denver Colorado United States 80262
    20 Lakewood Colorado United States 80260
    21 Stamford Connecticut United States 06902
    22 Ocala Florida United States 34471
    23 Pembroke Pines Florida United States 33028
    24 Atlanta Georgia United States 30342
    25 Augusta Georgia United States 30309
    26 Honolulu Hawaii United States 96813
    27 Maywood Illinois United States 60153
    28 South Holland Illinois United States 60473
    29 Louisville Kentucky United States 40202-1718
    30 Baton Rouge Louisiana United States 70884
    31 Shreveport Louisiana United States 71101
    32 Boston Massachusetts United States 02115
    33 Boston Massachusetts United States 02135
    34 Springfield Massachusetts United States 01107
    35 Detroit Michigan United States 48202-2689
    36 Detroit Michigan United States 48236
    37 Kalamazoo Michigan United States 49007
    38 Brooklyn Center Minnesota United States 55430
    39 Columbus Mississippi United States 39705
    40 Tupelo Mississippi United States 38801
    41 St Louis Missouri United States 63110
    42 Hackensack New Jersey United States 07601
    43 Paterson New Jersey United States 07503
    44 Albuquerque New Mexico United States 87131
    45 Bronx New York United States 10467
    46 Brooklyn New York United States 11203
    47 Flushing New York United States 11355
    48 Great Neck New York United States 11021
    49 Mineola New York United States 11501
    50 New York New York United States 10021
    51 New York New York United States 10128
    52 Orchard Park New York United States 14127
    53 Chapel Hill North Carolina United States 27599-7155
    54 Mount Airy North Carolina United States 27030
    55 Raleigh North Carolina United States 27609
    56 Cincinnati Ohio United States 45267-0585
    57 Cleveland Ohio United States 44109
    58 Toledo Ohio United States 43606
    59 Oregon City Oregon United States 97045
    60 Portland Oregon United States 97201-2940
    61 Portland Oregon United States 97210
    62 Allentown Pennsylvania United States 18103
    63 Erie Pennsylvania United States 16502
    64 Lewistown Pennsylvania United States 17044
    65 Philadelphia Pennsylvania United States 19106
    66 Philadelphia Pennsylvania United States 19140
    67 Philadelphia Pennsylvania United States 19141
    68 Pittsburgh Pennsylvania United States 15224
    69 Columbia South Carolina United States 29209
    70 Orangeburg South Carolina United States 29118
    71 Chattanooga Tennessee United States 37404
    72 Nashville Tennessee United States 37205
    73 Nashville Tennessee United States 37232
    74 Austin Texas United States 78758
    75 Dallas Texas United States 75216
    76 Houston Texas United States 77030
    77 Houston Texas United States 77054
    78 Houston Texas United States 77099
    79 Burlington Vermont United States 05401
    80 Fairfax Virginia United States 22031
    81 Norfolk Virginia United States 23507-1901
    82 Salem Virginia United States 24153
    83 Morgantown West Virginia United States 26506
    84 Clayton Australia 3186
    85 Gosford Australia 2250
    86 Liverpool Australia 1871
    87 Parkville Australia 3050
    88 Perth Australia 6847
    89 Sydney Australia NSW 2148
    90 Woolloongabba Australia 4102
    91 Graz Austria 8036
    92 Aalst Belgium 9300
    93 Bruxelles Belgium 1200
    94 Edegem Belgium 2650
    95 Gent Belgium 9000
    96 Hasselt Belgium 3500
    97 Leuven Belgium 3000
    98 Liege Belgium 4000
    99 Liberec Czech Republic 460 63
    100 Ostrava Czech Republic 708 52
    101 Plzen Czech Republic 304 60
    102 Aalborg Denmark 9100
    103 Odense Denmark 5000
    104 Roskilde Denmark 4000
    105 HUS Finland 00029
    106 Tampere Finland 33521
    107 Bayonne France 64115
    108 Bois Guillaume France 76233
    109 Bordeaux France 33076
    110 Boulogne France 62321
    111 Cabestany France 66330
    112 Caen France 14033
    113 Chambery France 73001
    114 Colmar France 68024
    115 Hyeres France 83400
    116 La Tronche France 38700
    117 Limoges France 87042
    118 Lyon France 69437
    119 Montpellier France 34295
    120 Nantes France 44093
    121 Nimes France 30029
    122 Paris France 75908
    123 Perpignan France 66046
    124 Poitiers France 86021
    125 Saint Ouen France 93400
    126 Saint-germain-en-laye France 78100
    127 Salouël France 80480
    128 Tarbes France 65013
    129 Thionville France 57126
    130 Toulouse France 31059
    131 Tours France 37044
    132 Bad Hersfeld Germany 36251
    133 Berlin Germany 12045
    134 Dortmund Germany 44263
    135 Erlangen Germany 91054
    136 München Germany 80804
    137 Nürnberg Germany 90431
    138 Stuttgart Germany 70191
    139 Villingen-schwenningen Germany 78054
    140 Wiesbaden Germany 65191
    141 Wiesloch Germany 69168
    142 Wuppertal Germany 42103
    143 Alexandroupolis Greece 68100
    144 Ioannina Greece 45500
    145 Larissa Greece 41110
    146 Piraeus Greece 18536
    147 Thessaloniki Greece 54629
    148 Budapest Hungary 1076
    149 Budapest Hungary 1134
    150 Debrecen Hungary 4032
    151 Miskolc Hungary 3526
    152 Pecs Hungary 7624
    153 Bergamo Italy 24128
    154 Cagliari Italy 91034
    155 Cremona Italy 26100
    156 Cuneo Italy 12100
    157 Genova Italy 16132
    158 Lecco Italy 23900
    159 Livorno Italy 57100
    160 Lodi Italy 26900
    161 Messina Italy 98158
    162 Mestre Italy 30174
    163 Modena Italy 41100
    164 Pavia Italy 27100
    165 Prato Italy 50047
    166 Reggio Calabria Italy 89100
    167 S Fermo Della Battaglia Italy 22020
    168 Venezia Italy 30122
    169 Cuernavaca Mexico 62448
    170 Mexico City Mexico 14000
    171 Heerlen Netherlands 6419 PC
    172 Trondheim Norway 7006
    173 Panama City Panama
    174 Gdansk Poland 80-211
    175 Gdynia Poland 81-519
    176 Kielce Poland 25-736
    177 Krakow Poland 31-501
    178 Lodz Poland 90-153
    179 Poznan Poland 60-355
    180 Rzeszow Poland 35-055
    181 Szczecin Poland 70-111
    182 Warszawa Poland 02-006
    183 Wolomin Poland 05-200
    184 Wroclaw Poland 50-417
    185 Setubal Portugal 2910-446
    186 Ponce Puerto Rico 00732
    187 Moscow Russian Federation 123182
    188 Moscow Russian Federation 125101
    189 Moscow Russian Federation 129110
    190 St Petersburg Russian Federation 195067
    191 St Petersburg Russian Federation 197089
    192 Cape Town South Africa 7925
    193 Durban South Africa
    194 Soweto South Africa
    195 Alcorcon Spain 28922
    196 Alicante Spain 03010
    197 Almería Spain 04009
    198 Badalona Spain 08915
    199 Barcelona Spain 08003
    200 Barcelona Spain 08035
    201 Barcelona Spain 08036
    202 Bilbao Spain 48013
    203 Córdoba Spain 14004
    204 Hospitalet de Llobregat Spain 08907
    205 La Coruna Spain 15006
    206 Lerida Spain 25198
    207 Madrid Spain 28006
    208 Madrid Spain 28007
    209 Madrid Spain 28041
    210 Madrid Spain 28046
    211 Madrid Spain 28222
    212 Madrid Spain 28805
    213 Malaga Spain 29010
    214 Oviedo Spain 33006
    215 Palma de Mallorca Spain 07014
    216 Palma de Mallorca Spain 07198
    217 Salamanca Spain 37008
    218 Santander Spain 39008
    219 Santiago de Compostela Spain 15706
    220 Sevilla Spain 41013
    221 Huddinge Sweden 14186
    222 Karlstad Sweden 65185
    223 Stockholm Sweden 18288
    224 Umea Sweden 90185
    225 Aarau Switzerland 5001
    226 Lausanne Switzerland 1003
    227 Lausanne Switzerland 1011
    228 Taichung Taiwan 407
    229 Taipei Taiwan 100
    230 Bangkok Thailand 10330
    231 Bangkok Thailand 10400
    232 Bangkok Thailand 10700
    233 Bangkok Thailand
    234 Chiang Mai Thailand 50200
    235 Chonburi Thailand
    236 Phitsanulok Thailand 65000
    237 Belfast United Kingdom BT9 7LJ
    238 Cambridge United Kingdom CB2 2QQ
    239 Carshalton United Kingdom SM5 1AA
    240 Dundee United Kingdom DD1 9SY
    241 Exeter United Kingdom EX2 5DW
    242 Glasgow United Kingdom G4 OSF
    243 Leicester United Kingdom LE5 4PW
    244 London United Kingdom E1 1BB
    245 London United Kingdom SE1 9RT
    246 London United Kingdom SE22 8PT
    247 London United Kingdom SW17 0RE
    248 Salford United Kingdom M6 8HD
    249 Swansea United Kingdom SA6 6NL

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT00090753
    Other Study ID Numbers:
    • BH18387
    First Posted:
    Sep 6, 2004
    Last Update Posted:
    Feb 14, 2012
    Last Verified:
    Feb 1, 2012
    Additional relevant MeSH terms:
    Anemia
    Epoetin Alfa
    Darbepoetin alfa

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled in one of the following Phase II or Phase III studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] or BA17284[NCT00081484]
    Pre-assignment Detail
    Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta Comparator ESA
    Arm/Group Description Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL. Patients received the same comparator erythropoiesis stimulating agent (ESA) [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
    Period Title: First Treatment Period
    STARTED 748 480
    COMPLETED 492 302
    NOT COMPLETED 256 178
    Period Title: First Treatment Period
    STARTED 453 250
    COMPLETED 94 59
    NOT COMPLETED 359 191

    Baseline Characteristics

    Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta Comparator ESA Total
    Arm/Group Description Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL. Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta. Total of all reporting groups
    Overall Participants 748 480 1228
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.2
    (14.80)
    61.9
    (14.42)
    61.5
    (14.65)
    Sex: Female, Male (Count of Participants)
    Female
    327
    43.7%
    223
    46.5%
    550
    44.8%
    Male
    421
    56.3%
    257
    53.5%
    678
    55.2%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
    Description Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.
    Time Frame Baseline to the end of the study (Up to 49 Months)

    Outcome Measure Data

    Analysis Population Description
    Analysis includes participants from the Intent-to-treat population (all patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA) who had hemoglobin values available for analysis.
    Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta Comparator ESA
    Arm/Group Description Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL. Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
    Measure Participants 735 476
    Mean (Standard Deviation) [g/dL]
    -0.55
    (1.832)
    -0.38
    (1.614)
    2. Secondary Outcome
    Title Percentage of Patients Who Had at Least 1 Adverse Event
    Description See the adverse events section of the results for more information.
    Time Frame From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
    Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta Comparator ESA
    Arm/Group Description Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL. Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
    Measure Participants 748 480
    Number [Percentage of participants]
    94.3
    12.6%
    93.3
    19.4%

    Adverse Events

    Time Frame From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)
    Adverse Event Reporting Description Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.
    Arm/Group Title Methoxy Polyethylene Glycol-Epoetin Beta Comparator ESA
    Arm/Group Description Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL. Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
    All Cause Mortality
    Methoxy Polyethylene Glycol-Epoetin Beta Comparator ESA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Methoxy Polyethylene Glycol-Epoetin Beta Comparator ESA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 499/748 (66.7%) 316/480 (65.8%)
    Blood and lymphatic system disorders
    ANAEMIA 10/748 (1.3%) 6/480 (1.3%)
    COAGULOPATHY 1/748 (0.1%) 0/480 (0%)
    DISSEMINATED INTRAVASCULAR COAGULATION 1/748 (0.1%) 0/480 (0%)
    HEPARIN-INDUCED THROMBOCYTOPENIA 1/748 (0.1%) 0/480 (0%)
    HYPOPROTHROMBINAEMIA 0/748 (0%) 1/480 (0.2%)
    LEUKOPENIA 0/748 (0%) 1/480 (0.2%)
    THROMBOCYTOPENIA 1/748 (0.1%) 0/480 (0%)
    Cardiac disorders
    MYOCARDIAL INFARCTION 27/748 (3.6%) 15/480 (3.1%)
    CARDIAC FAILURE CONGESTIVE 19/748 (2.5%) 21/480 (4.4%)
    ACUTE MYOCARDIAL INFARCTION 26/748 (3.5%) 10/480 (2.1%)
    ATRIAL FIBRILLATION 16/748 (2.1%) 19/480 (4%)
    CARDIAC ARREST 16/748 (2.1%) 11/480 (2.3%)
    ANGINA PECTORIS 16/748 (2.1%) 9/480 (1.9%)
    CORONARY ARTERY DISEASE 9/748 (1.2%) 9/480 (1.9%)
    ACUTE CORONARY SYNDROME 10/748 (1.3%) 3/480 (0.6%)
    CARDIO-RESPIRATORY ARREST 5/748 (0.7%) 6/480 (1.3%)
    MYOCARDIAL ISCHAEMIA 7/748 (0.9%) 4/480 (0.8%)
    ATRIAL FLUTTER 7/748 (0.9%) 3/480 (0.6%)
    VENTRICULAR FIBRILLATION 6/748 (0.8%) 4/480 (0.8%)
    BRADYCARDIA 8/748 (1.1%) 1/480 (0.2%)
    CARDIAC FAILURE 5/748 (0.7%) 3/480 (0.6%)
    ARRHYTHMIA 4/748 (0.5%) 2/480 (0.4%)
    CARDIOGENIC SHOCK 4/748 (0.5%) 1/480 (0.2%)
    CARDIOPULMONARY FAILURE 4/748 (0.5%) 1/480 (0.2%)
    ANGINA UNSTABLE 4/748 (0.5%) 0/480 (0%)
    ATRIOVENTRICULAR BLOCK COMPLETE 1/748 (0.1%) 3/480 (0.6%)
    CORONARY ARTERY STENOSIS 1/748 (0.1%) 3/480 (0.6%)
    PERICARDITIS 3/748 (0.4%) 1/480 (0.2%)
    VENTRICULAR TACHYCARDIA 3/748 (0.4%) 1/480 (0.2%)
    ARTERIOSCLEROSIS CORONARY ARTERY 3/748 (0.4%) 0/480 (0%)
    LEFT VENTRICULAR FAILURE 2/748 (0.3%) 1/480 (0.2%)
    MITRAL VALVE INCOMPETENCE 1/748 (0.1%) 2/480 (0.4%)
    SUPRAVENTRICULAR TACHYCARDIA 2/748 (0.3%) 1/480 (0.2%)
    TACHYCARDIA 2/748 (0.3%) 1/480 (0.2%)
    ATRIOVENTRICULAR BLOCK 1/748 (0.1%) 1/480 (0.2%)
    CARDIAC FAILURE CHRONIC 1/748 (0.1%) 1/480 (0.2%)
    COR PULMONALE 2/748 (0.3%) 0/480 (0%)
    CORONARY ARTERY OCCLUSION 1/748 (0.1%) 1/480 (0.2%)
    ISCHAEMIC CARDIOMYOPATHY 2/748 (0.3%) 0/480 (0%)
    PALPITATIONS 1/748 (0.1%) 1/480 (0.2%)
    SICK SINUS SYNDROME 1/748 (0.1%) 1/480 (0.2%)
    AORTIC VALVE STENOSIS 0/748 (0%) 1/480 (0.2%)
    ATRIOVENTRICULAR BLOCK FIRST DEGREE 1/748 (0.1%) 0/480 (0%)
    ATRIOVENTRICULAR DISSOCIATION 1/748 (0.1%) 0/480 (0%)
    BUNDLE BRANCH BLOCK RIGHT 1/748 (0.1%) 0/480 (0%)
    CARDIAC FAILURE ACUTE 0/748 (0%) 1/480 (0.2%)
    CARDIOMYOPATHY 0/748 (0%) 1/480 (0.2%)
    CARDIOVASCULAR DISORDER 1/748 (0.1%) 0/480 (0%)
    CONGESTIVE CARDIOMYOPATHY 1/748 (0.1%) 0/480 (0%)
    CORONARY ARTERY DISSECTION 1/748 (0.1%) 0/480 (0%)
    ELECTROMECHANICAL DISSOCIATION 0/748 (0%) 1/480 (0.2%)
    HYPERTENSIVE CARDIOMYOPATHY 0/748 (0%) 1/480 (0.2%)
    HYPERTENSIVE HEART DISEASE 1/748 (0.1%) 0/480 (0%)
    HYPERTROPHIC CARDIOMYOPATHY 1/748 (0.1%) 0/480 (0%)
    LEFT VENTRICULAR HYPERTROPHY 1/748 (0.1%) 0/480 (0%)
    NODAL ARRHYTHMIA 1/748 (0.1%) 0/480 (0%)
    PERICARDIAL DISEASE 0/748 (0%) 1/480 (0.2%)
    PERICARDIAL EFFUSION 1/748 (0.1%) 0/480 (0%)
    SINUS ARRHYTHMIA 1/748 (0.1%) 0/480 (0%)
    TACHYARRHYTHMIA 1/748 (0.1%) 0/480 (0%)
    VENTRICULAR ARRHYTHMIA 1/748 (0.1%) 0/480 (0%)
    VENTRICULAR EXTRASYSTOLES 0/748 (0%) 1/480 (0.2%)
    VENTRICULAR HYPERTROPHY 1/748 (0.1%) 0/480 (0%)
    Congenital, familial and genetic disorders
    GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC 2/748 (0.3%) 0/480 (0%)
    CONGENITAL CYSTIC KIDNEY DISEASE 1/748 (0.1%) 0/480 (0%)
    Ear and labyrinth disorders
    VERTIGO 0/748 (0%) 2/480 (0.4%)
    VERTIGO POSITIONAL 0/748 (0%) 1/480 (0.2%)
    Endocrine disorders
    HYPERPARATHYROIDISM SECONDARY 15/748 (2%) 6/480 (1.3%)
    HYPERPARATHYROIDISM TERTIARY 2/748 (0.3%) 2/480 (0.4%)
    HYPERPARATHYROIDISM 1/748 (0.1%) 2/480 (0.4%)
    HYPERTHYROIDISM 1/748 (0.1%) 1/480 (0.2%)
    GOITRE 1/748 (0.1%) 0/480 (0%)
    Eye disorders
    CATARACT 3/748 (0.4%) 4/480 (0.8%)
    CONJUNCTIVAL HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    GLAUCOMA 1/748 (0.1%) 0/480 (0%)
    RETINAL DETACHMENT 0/748 (0%) 1/480 (0.2%)
    Gastrointestinal disorders
    GASTROINTESTINAL HAEMORRHAGE 8/748 (1.1%) 8/480 (1.7%)
    PERITONITIS 8/748 (1.1%) 6/480 (1.3%)
    GASTRITIS 9/748 (1.2%) 3/480 (0.6%)
    DIARRHOEA 7/748 (0.9%) 4/480 (0.8%)
    PANCREATITIS 8/748 (1.1%) 2/480 (0.4%)
    UPPER GASTROINTESTINAL HAEMORRHAGE 5/748 (0.7%) 2/480 (0.4%)
    ABDOMINAL PAIN 4/748 (0.5%) 2/480 (0.4%)
    CONSTIPATION 2/748 (0.3%) 4/480 (0.8%)
    DIVERTICULUM INTESTINAL HAEMORRHAGIC 4/748 (0.5%) 2/480 (0.4%)
    GASTRIC ULCER HAEMORRHAGE 4/748 (0.5%) 2/480 (0.4%)
    VOMITING 4/748 (0.5%) 2/480 (0.4%)
    COLITIS ISCHAEMIC 5/748 (0.7%) 0/480 (0%)
    SMALL INTESTINAL OBSTRUCTION 3/748 (0.4%) 2/480 (0.4%)
    COLITIS 3/748 (0.4%) 1/480 (0.2%)
    COLONIC POLYP 3/748 (0.4%) 1/480 (0.2%)
    INTESTINAL INFARCTION 2/748 (0.3%) 2/480 (0.4%)
    MELAENA 2/748 (0.3%) 2/480 (0.4%)
    ABDOMINAL HERNIA 2/748 (0.3%) 1/480 (0.2%)
    DIVERTICULAR PERFORATION 1/748 (0.1%) 2/480 (0.4%)
    DUODENAL ULCER HAEMORRHAGE 2/748 (0.3%) 1/480 (0.2%)
    DUODENITIS 3/748 (0.4%) 0/480 (0%)
    GASTROOESOPHAGEAL REFLUX DISEASE 3/748 (0.4%) 0/480 (0%)
    HAEMORRHOIDS 0/748 (0%) 3/480 (0.6%)
    ILEUS 2/748 (0.3%) 1/480 (0.2%)
    INGUINAL HERNIA 1/748 (0.1%) 2/480 (0.4%)
    INTESTINAL ISCHAEMIA 2/748 (0.3%) 1/480 (0.2%)
    PANCREATITIS ACUTE 1/748 (0.1%) 2/480 (0.4%)
    RECTAL HAEMORRHAGE 2/748 (0.3%) 1/480 (0.2%)
    ABDOMINAL STRANGULATED HERNIA 2/748 (0.3%) 0/480 (0%)
    CAECITIS 0/748 (0%) 2/480 (0.4%)
    DIVERTICULUM 0/748 (0%) 2/480 (0.4%)
    DIVERTICULUM INTESTINAL 2/748 (0.3%) 0/480 (0%)
    DUODENAL ULCER 1/748 (0.1%) 1/480 (0.2%)
    GASTRITIS HAEMORRHAGIC 2/748 (0.3%) 0/480 (0%)
    INTESTINAL OBSTRUCTION 1/748 (0.1%) 1/480 (0.2%)
    LARGE INTESTINAL HAEMORRHAGE 1/748 (0.1%) 1/480 (0.2%)
    PANCREATITIS CHRONIC 1/748 (0.1%) 1/480 (0.2%)
    REFLUX OESOPHAGITIS 2/748 (0.3%) 0/480 (0%)
    SUBILEUS 1/748 (0.1%) 1/480 (0.2%)
    ABDOMINAL HERNIA OBSTRUCTIVE 1/748 (0.1%) 0/480 (0%)
    ABDOMINAL PAIN UPPER 0/748 (0%) 1/480 (0.2%)
    ACUTE ABDOMEN 0/748 (0%) 1/480 (0.2%)
    ASCITES 1/748 (0.1%) 0/480 (0%)
    DIVERTICULITIS INTESTINAL HAEMORRHAGIC 1/748 (0.1%) 0/480 (0%)
    DUODENAL OBSTRUCTION 1/748 (0.1%) 0/480 (0%)
    DUODENAL ULCER PERFORATION 1/748 (0.1%) 0/480 (0%)
    DUODENITIS HAEMORRHAGIC 1/748 (0.1%) 0/480 (0%)
    DYSPHAGIA 1/748 (0.1%) 0/480 (0%)
    EROSIVE DUODENITIS 0/748 (0%) 1/480 (0.2%)
    EROSIVE OESOPHAGITIS 1/748 (0.1%) 0/480 (0%)
    FLATULENCE 0/748 (0%) 1/480 (0.2%)
    GASTRIC DISORDER 1/748 (0.1%) 0/480 (0%)
    GASTRITIS EROSIVE 1/748 (0.1%) 0/480 (0%)
    GASTRODUODENITIS 1/748 (0.1%) 0/480 (0%)
    GASTROINTESTINAL DISORDER 0/748 (0%) 1/480 (0.2%)
    GASTROINTESTINAL OBSTRUCTION 0/748 (0%) 1/480 (0.2%)
    GASTROINTESTINAL TELANGIECTASIA 0/748 (0%) 1/480 (0.2%)
    GASTROINTESTINAL ULCER HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    HAEMATEMESIS 0/748 (0%) 1/480 (0.2%)
    ILEUS PARALYTIC 1/748 (0.1%) 0/480 (0%)
    INTESTINAL PERFORATION 1/748 (0.1%) 0/480 (0%)
    IRRITABLE BOWEL SYNDROME 1/748 (0.1%) 0/480 (0%)
    LOWER GASTROINTESTINAL HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    MEGACOLON 1/748 (0.1%) 0/480 (0%)
    PEPTIC ULCER 1/748 (0.1%) 0/480 (0%)
    RETROPERITONEAL FIBROSIS 0/748 (0%) 1/480 (0.2%)
    RETROPERITONEAL HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    SMALL INTESTINAL HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    General disorders
    DEATH 7/748 (0.9%) 8/480 (1.7%)
    PYREXIA 10/748 (1.3%) 5/480 (1%)
    NON-CARDIAC CHEST PAIN 9/748 (1.2%) 4/480 (0.8%)
    CATHETER THROMBOSIS 3/748 (0.4%) 4/480 (0.8%)
    SUDDEN DEATH 2/748 (0.3%) 4/480 (0.8%)
    CATHETER RELATED COMPLICATION 2/748 (0.3%) 3/480 (0.6%)
    CHEST PAIN 2/748 (0.3%) 2/480 (0.4%)
    MULTI-ORGAN FAILURE 2/748 (0.3%) 2/480 (0.4%)
    ASTHENIA 2/748 (0.3%) 1/480 (0.2%)
    GENERAL PHYSICAL HEALTH DETERIORATION 3/748 (0.4%) 0/480 (0%)
    HYPERPYREXIA 3/748 (0.4%) 0/480 (0%)
    HERNIA OBSTRUCTIVE 2/748 (0.3%) 0/480 (0%)
    HYPERTHERMIA 1/748 (0.1%) 1/480 (0.2%)
    SUDDEN CARDIAC DEATH 2/748 (0.3%) 0/480 (0%)
    VESSEL PUNCTURE SITE HAEMATOMA 2/748 (0.3%) 0/480 (0%)
    CALCINOSIS 1/748 (0.1%) 0/480 (0%)
    CATHETER SITE HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    CHEST DISCOMFORT 1/748 (0.1%) 0/480 (0%)
    CHILLS 1/748 (0.1%) 0/480 (0%)
    IMPAIRED HEALING 0/748 (0%) 1/480 (0.2%)
    IMPLANT SITE NECROSIS 0/748 (0%) 1/480 (0.2%)
    INFLAMMATION 0/748 (0%) 1/480 (0.2%)
    MULTI-ORGAN DISORDER 0/748 (0%) 1/480 (0.2%)
    OEDEMA DUE TO RENAL DISEASE 0/748 (0%) 1/480 (0.2%)
    PAIN 1/748 (0.1%) 0/480 (0%)
    PSEUDOCYST 0/748 (0%) 1/480 (0.2%)
    Hepatobiliary disorders
    CHOLELITHIASIS 7/748 (0.9%) 2/480 (0.4%)
    CHOLECYSTITIS 4/748 (0.5%) 1/480 (0.2%)
    CHOLECYSTITIS ACUTE 3/748 (0.4%) 1/480 (0.2%)
    BILE DUCT OBSTRUCTION 1/748 (0.1%) 0/480 (0%)
    BILE DUCT STENOSIS 1/748 (0.1%) 0/480 (0%)
    BILE DUCT STONE 1/748 (0.1%) 0/480 (0%)
    GALLBLADDER POLYP 1/748 (0.1%) 0/480 (0%)
    HEPATIC CIRRHOSIS 1/748 (0.1%) 0/480 (0%)
    HEPATIC CONGESTION 1/748 (0.1%) 0/480 (0%)
    HEPATIC FIBROSIS 1/748 (0.1%) 0/480 (0%)
    HEPATITIS 1/748 (0.1%) 0/480 (0%)
    HEPATOSPLENOMEGALY 0/748 (0%) 1/480 (0.2%)
    JAUNDICE CHOLESTATIC 1/748 (0.1%) 0/480 (0%)
    Immune system disorders
    KIDNEY TRANSPLANT REJECTION 0/748 (0%) 3/480 (0.6%)
    ANAPHYLACTIC REACTION 1/748 (0.1%) 0/480 (0%)
    ANAPHYLACTOID REACTION 0/748 (0%) 1/480 (0.2%)
    CONTRAST MEDIA ALLERGY 0/748 (0%) 1/480 (0.2%)
    DRUG HYPERSENSITIVITY 1/748 (0.1%) 0/480 (0%)
    Infections and infestations
    PNEUMONIA 53/748 (7.1%) 35/480 (7.3%)
    SEPSIS 24/748 (3.2%) 12/480 (2.5%)
    CELLULITIS 15/748 (2%) 7/480 (1.5%)
    BRONCHITIS 10/748 (1.3%) 8/480 (1.7%)
    GASTROENTERITIS 11/748 (1.5%) 4/480 (0.8%)
    CATHETER SEPSIS 7/748 (0.9%) 6/480 (1.3%)
    ARTERIOVENOUS GRAFT SITE INFECTION 7/748 (0.9%) 5/480 (1%)
    GANGRENE 7/748 (0.9%) 5/480 (1%)
    SEPTIC SHOCK 8/748 (1.1%) 4/480 (0.8%)
    BRONCHOPNEUMONIA 6/748 (0.8%) 5/480 (1%)
    CATHETER RELATED INFECTION 8/748 (1.1%) 3/480 (0.6%)
    URINARY TRACT INFECTION 7/748 (0.9%) 4/480 (0.8%)
    STAPHYLOCOCCAL SEPSIS 6/748 (0.8%) 4/480 (0.8%)
    CLOSTRIDIUM DIFFICILE COLITIS 5/748 (0.7%) 4/480 (0.8%)
    STAPHYLOCOCCAL BACTERAEMIA 6/748 (0.8%) 3/480 (0.6%)
    GASTROENTERITIS VIRAL 5/748 (0.7%) 3/480 (0.6%)
    OSTEOMYELITIS 5/748 (0.7%) 3/480 (0.6%)
    DIABETIC GANGRENE 5/748 (0.7%) 2/480 (0.4%)
    DIVERTICULITIS 6/748 (0.8%) 1/480 (0.2%)
    CENTRAL LINE INFECTION 4/748 (0.5%) 2/480 (0.4%)
    UPPER RESPIRATORY TRACT INFECTION 4/748 (0.5%) 2/480 (0.4%)
    APPENDICITIS 4/748 (0.5%) 1/480 (0.2%)
    ARTERIOVENOUS FISTULA SITE INFECTION 1/748 (0.1%) 4/480 (0.8%)
    ENDOCARDITIS 3/748 (0.4%) 2/480 (0.4%)
    LOWER RESPIRATORY TRACT INFECTION 4/748 (0.5%) 1/480 (0.2%)
    POSTOPERATIVE WOUND INFECTION 3/748 (0.4%) 2/480 (0.4%)
    UROSEPSIS 4/748 (0.5%) 1/480 (0.2%)
    INFECTED SKIN ULCER 4/748 (0.5%) 0/480 (0%)
    PERITONITIS BACTERIAL 1/748 (0.1%) 3/480 (0.6%)
    WOUND INFECTION 3/748 (0.4%) 1/480 (0.2%)
    BACTERAEMIA 2/748 (0.3%) 1/480 (0.2%)
    CATHETER BACTERAEMIA 3/748 (0.4%) 0/480 (0%)
    CHOLECYSTITIS INFECTIVE 2/748 (0.3%) 1/480 (0.2%)
    DIABETIC FOOT INFECTION 1/748 (0.1%) 2/480 (0.4%)
    INTERVERTEBRAL DISCITIS 2/748 (0.3%) 1/480 (0.2%)
    LUNG INFECTION 2/748 (0.3%) 1/480 (0.2%)
    ABDOMINAL WALL ABSCESS 1/748 (0.1%) 1/480 (0.2%)
    ABSCESS LIMB 1/748 (0.1%) 1/480 (0.2%)
    BACTERIAL INFECTION 2/748 (0.3%) 0/480 (0%)
    BACTERIAL SEPSIS 1/748 (0.1%) 1/480 (0.2%)
    CATHETER SITE INFECTION 2/748 (0.3%) 0/480 (0%)
    CELLULITIS GANGRENOUS 2/748 (0.3%) 0/480 (0%)
    ERYSIPELAS 0/748 (0%) 2/480 (0.4%)
    FUNGAEMIA 2/748 (0.3%) 0/480 (0%)
    GRAFT INFECTION 1/748 (0.1%) 1/480 (0.2%)
    GROIN ABSCESS 1/748 (0.1%) 1/480 (0.2%)
    PNEUMONIA STAPHYLOCOCCAL 2/748 (0.3%) 0/480 (0%)
    PNEUMONIA STREPTOCOCCAL 2/748 (0.3%) 0/480 (0%)
    PYELONEPHRITIS 2/748 (0.3%) 0/480 (0%)
    STAPHYLOCOCCAL INFECTION 1/748 (0.1%) 1/480 (0.2%)
    STREPTOCOCCAL SEPSIS 1/748 (0.1%) 1/480 (0.2%)
    VIRAL INFECTION 1/748 (0.1%) 1/480 (0.2%)
    ABDOMINAL SEPSIS 0/748 (0%) 1/480 (0.2%)
    ANOGENITAL WARTS 1/748 (0.1%) 0/480 (0%)
    ARTERIOSCLEROTIC GANGRENE 0/748 (0%) 1/480 (0.2%)
    ARTERITIS INFECTIVE 0/748 (0%) 1/480 (0.2%)
    ARTHRITIS BACTERIAL 0/748 (0%) 1/480 (0.2%)
    ARTHRITIS INFECTIVE 0/748 (0%) 1/480 (0.2%)
    BACTERIAL DIARRHOEA 0/748 (0%) 1/480 (0.2%)
    BALANOPOSTHITIS INFECTIVE 1/748 (0.1%) 0/480 (0%)
    CELLULITIS OF MALE EXTERNAL 1/748 (0.1%) 0/480 (0%)
    GENITAL ORGAN CELLULITIS STREPTOCOCCAL 1/748 (0.1%) 0/480 (0%)
    CHRONIC TONSILLITIS 0/748 (0%) 1/480 (0.2%)
    CYSTITIS 0/748 (0%) 1/480 (0.2%)
    DISSEMINATED TUBERCULOSIS 0/748 (0%) 1/480 (0.2%)
    EMPHYSEMATOUS CHOLECYSTITIS 1/748 (0.1%) 0/480 (0%)
    EMPYEMA 1/748 (0.1%) 0/480 (0%)
    ENDOCARDITIS STAPHYLOCOCCAL 1/748 (0.1%) 0/480 (0%)
    ENTEROCOCCAL SEPSIS 0/748 (0%) 1/480 (0.2%)
    ESCHERICHIA SEPSIS 1/748 (0.1%) 0/480 (0%)
    ESCHERICHIA URINARY TRACT INFECTION 1/748 (0.1%) 0/480 (0%)
    EYE INFECTION STAPHYLOCOCCAL 1/748 (0.1%) 0/480 (0%)
    FUNGAL PERITONITIS 0/748 (0%) 1/480 (0.2%)
    GASTRIC ULCER HELICOBACTER 0/748 (0%) 1/480 (0.2%)
    HAEMATOMA INFECTION 0/748 (0%) 1/480 (0.2%)
    HEPATITIS C 1/748 (0.1%) 0/480 (0%)
    INFECTED BITES 1/748 (0.1%) 0/480 (0%)
    INFECTED CYST 1/748 (0.1%) 0/480 (0%)
    INFECTION 0/748 (0%) 1/480 (0.2%)
    INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE 0/748 (0%) 1/480 (0.2%)
    INFLUENZA 1/748 (0.1%) 0/480 (0%)
    KLEBSIELLA SEPSIS 1/748 (0.1%) 0/480 (0%)
    LIVER ABSCESS 1/748 (0.1%) 0/480 (0%)
    LOBAR PNEUMONIA 0/748 (0%) 1/480 (0.2%)
    LOCALISED INFECTION 0/748 (0%) 1/480 (0.2%)
    NOSOCOMIAL INFECTION 1/748 (0.1%) 0/480 (0%)
    ORAL INFECTION 0/748 (0%) 1/480 (0.2%)
    OSTEOMYELITIS CHRONIC 0/748 (0%) 1/480 (0.2%)
    PANCREAS INFECTION 0/748 (0%) 1/480 (0.2%)
    PAROTID ABSCESS 1/748 (0.1%) 0/480 (0%)
    PHARYNGEAL ABSCESS 1/748 (0.1%) 0/480 (0%)
    PHARYNGITIS 1/748 (0.1%) 0/480 (0%)
    PNEUMOCOCCAL SEPSIS 1/748 (0.1%) 0/480 (0%)
    PNEUMONIA BACTERIAL 1/748 (0.1%) 0/480 (0%)
    PNEUMONIA KLEBSIELLA 1/748 (0.1%) 0/480 (0%)
    PNEUMONIA PRIMARY ATYPICAL 0/748 (0%) 1/480 (0.2%)
    POST PROCEDURAL INFECTION 0/748 (0%) 1/480 (0.2%)
    POST PROCEDURAL SEPSIS 1/748 (0.1%) 0/480 (0%)
    PSEUDOMEMBRANOUS COLITIS 1/748 (0.1%) 0/480 (0%)
    PULMONARY SEPSIS 0/748 (0%) 1/480 (0.2%)
    PULMONARY TUBERCULOSIS 1/748 (0.1%) 0/480 (0%)
    RECTAL ABSCESS 1/748 (0.1%) 0/480 (0%)
    RESPIRATORY TRACT INFECTION 0/748 (0%) 1/480 (0.2%)
    RESPIRATORY TRACT INFECTION VIRAL 0/748 (0%) 1/480 (0.2%)
    SEPTIC ARTHRITIS STAPHYLOCOCCAL 1/748 (0.1%) 0/480 (0%)
    SERRATIA BACTERAEMIA 1/748 (0.1%) 0/480 (0%)
    SERRATIA INFECTION 1/748 (0.1%) 0/480 (0%)
    STAPHYLOCOCCAL ABSCESS 1/748 (0.1%) 0/480 (0%)
    STAPHYLOCOCCAL OSTEOMYELITIS 1/748 (0.1%) 0/480 (0%)
    SUBCUTANEOUS ABSCESS 0/748 (0%) 1/480 (0.2%)
    TUBERCULOSIS 1/748 (0.1%) 0/480 (0%)
    TUBERCULOUS PLEURISY 1/748 (0.1%) 0/480 (0%)
    WEST NILE VIRAL INFECTION 1/748 (0.1%) 0/480 (0%)
    Injury, poisoning and procedural complications
    ARTERIOVENOUS FISTULA THROMBOSIS 26/748 (3.5%) 20/480 (4.2%)
    ARTERIOVENOUS GRAFT THROMBOSIS 16/748 (2.1%) 8/480 (1.7%)
    ARTERIOVENOUS FISTULA SITE COMPLICATION 6/748 (0.8%) 9/480 (1.9%)
    FEMORAL NECK FRACTURE 11/748 (1.5%) 3/480 (0.6%)
    ARTERIOVENOUS FISTULA SITE HAEMORRHAGE 7/748 (0.9%) 4/480 (0.8%)
    PROCEDURAL HYPOTENSION 9/748 (1.2%) 2/480 (0.4%)
    VASCULAR GRAFT COMPLICATION 6/748 (0.8%) 4/480 (0.8%)
    FEMUR FRACTURE 5/748 (0.7%) 4/480 (0.8%)
    POST PROCEDURAL HAEMORRHAGE 7/748 (0.9%) 2/480 (0.4%)
    SUBDURAL HAEMATOMA 3/748 (0.4%) 6/480 (1.3%)
    HIP FRACTURE 5/748 (0.7%) 3/480 (0.6%)
    ARTERIOVENOUS FISTULA ANEURYSM 4/748 (0.5%) 3/480 (0.6%)
    POST PROCEDURAL HAEMATOMA 5/748 (0.7%) 2/480 (0.4%)
    PELVIC FRACTURE 2/748 (0.3%) 3/480 (0.6%)
    ARTERIOVENOUS GRAFT SITE HAEMORRHAGE 3/748 (0.4%) 1/480 (0.2%)
    TENDON RUPTURE 2/748 (0.3%) 2/480 (0.4%)
    GRAFT THROMBOSIS 1/748 (0.1%) 2/480 (0.4%)
    HEAD INJURY 2/748 (0.3%) 1/480 (0.2%)
    INCISIONAL HERNIA 2/748 (0.3%) 1/480 (0.2%)
    OVERDOSE 2/748 (0.3%) 1/480 (0.2%)
    RADIUS FRACTURE 2/748 (0.3%) 1/480 (0.2%)
    VASCULAR PSEUDOANEURYSM 2/748 (0.3%) 1/480 (0.2%)
    WRIST FRACTURE 2/748 (0.3%) 1/480 (0.2%)
    ANAEMIA POSTOPERATIVE 2/748 (0.3%) 0/480 (0%)
    ANKLE FRACTURE 0/748 (0%) 2/480 (0.4%)
    CONCUSSION 2/748 (0.3%) 0/480 (0%)
    FACIAL BONES FRACTURE 1/748 (0.1%) 1/480 (0.2%)
    FIBULA FRACTURE 1/748 (0.1%) 1/480 (0.2%)
    HUMERUS FRACTURE 2/748 (0.3%) 0/480 (0%)
    IN-STENT CORONARY ARTERY RESTENOSIS 0/748 (0%) 2/480 (0.4%)
    JOINT INJURY 2/748 (0.3%) 0/480 (0%)
    LOWER LIMB FRACTURE 2/748 (0.3%) 0/480 (0%)
    MULTIPLE FRACTURES 2/748 (0.3%) 0/480 (0%)
    PNEUMOTHORAX TRAUMATIC 1/748 (0.1%) 1/480 (0.2%)
    POST PROCEDURAL COMPLICATION 0/748 (0%) 2/480 (0.4%)
    PUBIC RAMI FRACTURE 2/748 (0.3%) 0/480 (0%)
    RIB FRACTURE 0/748 (0%) 2/480 (0.4%)
    THERAPEUTIC AGENT TOXICITY 0/748 (0%) 2/480 (0.4%)
    TIBIA FRACTURE 1/748 (0.1%) 1/480 (0.2%)
    ACETABULUM FRACTURE 1/748 (0.1%) 0/480 (0%)
    ALCOHOL POISONING 1/748 (0.1%) 0/480 (0%)
    ARTERIOVENOUS FISTULA OCCLUSION 0/748 (0%) 1/480 (0.2%)
    ARTERIOVENOUS FISTULA SITE HAEMATOMA 0/748 (0%) 1/480 (0.2%)
    ARTERIOVENOUS GRAFT ANEURYSM 0/748 (0%) 1/480 (0.2%)
    CHEST INJURY 1/748 (0.1%) 0/480 (0%)
    CLAVICLE FRACTURE 1/748 (0.1%) 0/480 (0%)
    CONTUSION 1/748 (0.1%) 0/480 (0%)
    DELAYED RECOVERY FROM ANAESTHESIA 0/748 (0%) 1/480 (0.2%)
    DEVICE MALFUNCTION 0/748 (0%) 1/480 (0.2%)
    DIALYSIS DEVICE COMPLICATION 1/748 (0.1%) 0/480 (0%)
    DISLOCATION OF JOINT PROSTHESIS 1/748 (0.1%) 0/480 (0%)
    FALL 0/748 (0%) 1/480 (0.2%)
    FOOT FRACTURE 0/748 (0%) 1/480 (0.2%)
    FOREARM FRACTURE 1/748 (0.1%) 0/480 (0%)
    FRACTURED COCCYX 0/748 (0%) 1/480 (0.2%)
    HEPATIC HAEMATOMA 1/748 (0.1%) 0/480 (0%)
    JOINT DISLOCATION 0/748 (0%) 1/480 (0.2%)
    LUMBAR VERTEBRAL FRACTURE 1/748 (0.1%) 0/480 (0%)
    MUSCLE RUPTURE 1/748 (0.1%) 0/480 (0%)
    PERIORBITAL HAEMATOMA 0/748 (0%) 1/480 (0.2%)
    PERIRENAL HAEMATOMA 1/748 (0.1%) 0/480 (0%)
    POST PROCEDURAL MYOCARDIAL INFARCTION 0/748 (0%) 1/480 (0.2%)
    POST PROCEDURAL PULMONARY EMBOLISM 0/748 (0%) 1/480 (0.2%)
    POSTOPERATIVE FEVER 0/748 (0%) 1/480 (0.2%)
    POSTOPERATIVE WOUND COMPLICATION 0/748 (0%) 1/480 (0.2%)
    POSTPERICARDIOTOMY SYNDROME 1/748 (0.1%) 0/480 (0%)
    PROCEDURAL COMPLICATION 0/748 (0%) 1/480 (0.2%)
    PROCEDURAL PAIN 1/748 (0.1%) 0/480 (0%)
    PROCEDURAL VOMITING 1/748 (0.1%) 0/480 (0%)
    SKULL FRACTURE 1/748 (0.1%) 0/480 (0%)
    SOFT TISSUE INJURY 0/748 (0%) 1/480 (0.2%)
    SPLENIC RUPTURE 1/748 (0.1%) 0/480 (0%)
    SUBDURAL HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    SYNOVIAL RUPTURE 0/748 (0%) 1/480 (0.2%)
    ULNA FRACTURE 0/748 (0%) 1/480 (0.2%)
    UPPER LIMB FRACTURE 0/748 (0%) 1/480 (0.2%)
    UROSTOMY COMPLICATION 1/748 (0.1%) 0/480 (0%)
    VASCULAR GRAFT OCCLUSION 0/748 (0%) 1/480 (0.2%)
    WOUND 1/748 (0.1%) 0/480 (0%)
    Investigations
    BACTERIAL CULTURE POSITIVE 0/748 (0%) 1/480 (0.2%)
    Metabolism and nutrition disorders
    FLUID OVERLOAD 16/748 (2.1%) 11/480 (2.3%)
    HYPERKALAEMIA 15/748 (2%) 12/480 (2.5%)
    HYPOGLYCAEMIA 7/748 (0.9%) 10/480 (2.1%)
    DIABETIC FOOT 3/748 (0.4%) 7/480 (1.5%)
    CACHEXIA 4/748 (0.5%) 5/480 (1%)
    DIABETES MELLITUS INADEQUATE CONTROL 4/748 (0.5%) 3/480 (0.6%)
    HYPOCALCAEMIA 2/748 (0.3%) 3/480 (0.6%)
    DEHYDRATION 3/748 (0.4%) 1/480 (0.2%)
    HYPERGLYCAEMIA 2/748 (0.3%) 2/480 (0.4%)
    GOUT 3/748 (0.4%) 0/480 (0%)
    HYPERCALCAEMIA 2/748 (0.3%) 1/480 (0.2%)
    CALCIPHYLAXIS 1/748 (0.1%) 1/480 (0.2%)
    DIABETES MELLITUS 0/748 (0%) 1/480 (0.2%)
    ELECTROLYTE IMBALANCE 0/748 (0%) 1/480 (0.2%)
    FAILURE TO THRIVE 0/748 (0%) 1/480 (0.2%)
    FLUID RETENTION 0/748 (0%) 1/480 (0.2%)
    HYPERVOLAEMIA 1/748 (0.1%) 0/480 (0%)
    HYPONATRAEMIA 0/748 (0%) 1/480 (0.2%)
    HYPOVOLAEMIA 0/748 (0%) 1/480 (0.2%)
    Musculoskeletal and connective tissue disorders
    OSTEOARTHRITIS 4/748 (0.5%) 4/480 (0.8%)
    BACK PAIN 4/748 (0.5%) 0/480 (0%)
    SPINAL OSTEOARTHRITIS 2/748 (0.3%) 2/480 (0.4%)
    ARTHRALGIA 0/748 (0%) 2/480 (0.4%)
    ARTHRITIS 2/748 (0.3%) 0/480 (0%)
    INTERVERTEBRAL DISC DISORDER 1/748 (0.1%) 1/480 (0.2%)
    MUSCULAR WEAKNESS 1/748 (0.1%) 1/480 (0.2%)
    PAIN IN EXTREMITY 1/748 (0.1%) 1/480 (0.2%)
    CERVICAL SPINAL STENOSIS 1/748 (0.1%) 0/480 (0%)
    COSTOCHONDRITIS 1/748 (0.1%) 0/480 (0%)
    DACTYLITIS 1/748 (0.1%) 0/480 (0%)
    FASCIITIS 1/748 (0.1%) 0/480 (0%)
    FLANK PAIN 1/748 (0.1%) 0/480 (0%)
    HAEMARTHROSIS 0/748 (0%) 1/480 (0.2%)
    INTERVERTEBRAL DISC PROTRUSION 0/748 (0%) 1/480 (0.2%)
    MUSCLE HAEMORRHAGE 0/748 (0%) 1/480 (0.2%)
    MUSCULOSKELETAL CHEST PAIN 1/748 (0.1%) 0/480 (0%)
    MYOPATHY 1/748 (0.1%) 0/480 (0%)
    OSTEITIS 1/748 (0.1%) 0/480 (0%)
    OSTEODYSTROPHY 1/748 (0.1%) 0/480 (0%)
    OSTEOLYSIS 0/748 (0%) 1/480 (0.2%)
    OSTEONECROSIS 1/748 (0.1%) 0/480 (0%)
    OSTEOPOROSIS 1/748 (0.1%) 0/480 (0%)
    POLYMYALGIA RHEUMATICA 1/748 (0.1%) 0/480 (0%)
    ROTATOR CUFF SYNDROME 1/748 (0.1%) 0/480 (0%)
    SOFT TISSUE NECROSIS 1/748 (0.1%) 0/480 (0%)
    SPINAL COLUMN STENOSIS 1/748 (0.1%) 0/480 (0%)
    SYNOVITIS 1/748 (0.1%) 0/480 (0%)
    MUSCULOSKELETAL PAIN 2/748 (0.3%) 1/480 (0.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    COLON CANCER 5/748 (0.7%) 2/480 (0.4%)
    PROSTATE CANCER 4/748 (0.5%) 1/480 (0.2%)
    LUNG NEOPLASM 2/748 (0.3%) 2/480 (0.4%)
    BREAST CANCER 2/748 (0.3%) 1/480 (0.2%)
    LUNG CANCER METASTATIC 0/748 (0%) 3/480 (0.6%)
    LUNG NEOPLASM MALIGNANT 3/748 (0.4%) 0/480 (0%)
    RENAL CELL CARCINOMA 2/748 (0.3%) 1/480 (0.2%)
    BLADDER TRANSITIONAL CELL CARCINOMA 2/748 (0.3%) 0/480 (0%)
    COLON CANCER METASTATIC 2/748 (0.3%) 0/480 (0%)
    LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED 2/748 (0.3%) 0/480 (0%)
    METASTATIC NEOPLASM 1/748 (0.1%) 1/480 (0.2%)
    PANCREATIC CARCINOMA METASTATIC 1/748 (0.1%) 1/480 (0.2%)
    RENAL NEOPLASM 2/748 (0.3%) 0/480 (0%)
    ADENOID CYSTIC CARCINOMA 1/748 (0.1%) 0/480 (0%)
    BASAL CELL CARCINOMA 0/748 (0%) 1/480 (0.2%)
    BLADDER NEOPLASM 1/748 (0.1%) 0/480 (0%)
    BREAST CANCER IN SITU 0/748 (0%) 1/480 (0.2%)
    BREAST CANCER METASTATIC 1/748 (0.1%) 0/480 (0%)
    CHRONIC LYMPHOCYTIC LEUKAEMIA 1/748 (0.1%) 0/480 (0%)
    COLON ADENOMA 0/748 (0%) 1/480 (0.2%)
    LUNG ADENOCARCINOMA 1/748 (0.1%) 0/480 (0%)
    MALIGNANT PLEURAL EFFUSION 0/748 (0%) 1/480 (0.2%)
    METASTASES TO CENTRAL NERVOUS SYSTEM 1/748 (0.1%) 0/480 (0%)
    METASTASES TO LIVER 1/748 (0.1%) 0/480 (0%)
    METASTATIC GASTRIC CANCER 0/748 (0%) 1/480 (0.2%)
    MULTIPLE MYELOMA 0/748 (0%) 1/480 (0.2%)
    PANCREATIC NEOPLASM 1/748 (0.1%) 0/480 (0%)
    PARATHYROID TUMOUR 0/748 (0%) 1/480 (0.2%)
    PROSTATE CANCER METASTATIC 1/748 (0.1%) 0/480 (0%)
    RENAL CANCER 0/748 (0%) 1/480 (0.2%)
    RENAL ONCOCYTOMA 1/748 (0.1%) 0/480 (0%)
    SKIN CANCER 1/748 (0.1%) 0/480 (0%)
    SMALL CELL LUNG CANCER METASTATIC 1/748 (0.1%) 0/480 (0%)
    SMALL CELL LUNG CANCER STAGE UNSPECIFIED 0/748 (0%) 1/480 (0.2%)
    SQUAMOUS CELL CARCINOMA OF SKIN 1/748 (0.1%) 0/480 (0%)
    THYROID CANCER 1/748 (0.1%) 0/480 (0%)
    THYROID NEOPLASM 1/748 (0.1%) 0/480 (0%)
    URINARY TRACT NEOPLASM 1/748 (0.1%) 0/480 (0%)
    UTERINE LEIOMYOMA 0/748 (0%) 1/480 (0.2%)
    Nervous system disorders
    CEREBROVASCULAR ACCIDENT 7/748 (0.9%) 8/480 (1.7%)
    TRANSIENT ISCHAEMIC ATTACK 6/748 (0.8%) 6/480 (1.3%)
    CEREBRAL HAEMORRHAGE 8/748 (1.1%) 0/480 (0%)
    ISCHAEMIC STROKE 5/748 (0.7%) 3/480 (0.6%)
    CEREBRAL INFARCTION 4/748 (0.5%) 3/480 (0.6%)
    SYNCOPE 5/748 (0.7%) 2/480 (0.4%)
    CAROTID ARTERY STENOSIS 5/748 (0.7%) 1/480 (0.2%)
    CARPAL TUNNEL SYNDROME 5/748 (0.7%) 1/480 (0.2%)
    HAEMORRHAGIC STROKE 4/748 (0.5%) 1/480 (0.2%)
    CEREBROVASCULAR DISORDER 3/748 (0.4%) 1/480 (0.2%)
    CONVULSION 3/748 (0.4%) 1/480 (0.2%)
    CEREBRAL ISCHAEMIA 3/748 (0.4%) 0/480 (0%)
    ISCHAEMIC CEREBRAL INFARCTION 2/748 (0.3%) 1/480 (0.2%)
    PRESYNCOPE 2/748 (0.3%) 1/480 (0.2%)
    DIZZINESS 2/748 (0.3%) 0/480 (0%)
    EMBOLIC CEREBRAL INFARCTION 1/748 (0.1%) 1/480 (0.2%)
    EMBOLIC STROKE 1/748 (0.1%) 1/480 (0.2%)
    EPILEPSY 0/748 (0%) 2/480 (0.4%)
    HAEMORRHAGE INTRACRANIAL 0/748 (0%) 2/480 (0.4%)
    HEADACHE 1/748 (0.1%) 1/480 (0.2%)
    HYPOGLYCAEMIC COMA 2/748 (0.3%) 0/480 (0%)
    HYPOXIC ENCEPHALOPATHY 1/748 (0.1%) 1/480 (0.2%)
    LACUNAR INFARCTION 1/748 (0.1%) 1/480 (0.2%)
    REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT 1/748 (0.1%) 1/480 (0.2%)
    URAEMIC NEUROPATHY 2/748 (0.3%) 0/480 (0%)
    ALTERED STATE OF CONSCIOUSNESS 1/748 (0.1%) 0/480 (0%)
    ANOXIC ENCEPHALOPATHY 1/748 (0.1%) 0/480 (0%)
    BALANCE DISORDER 1/748 (0.1%) 0/480 (0%)
    BENIGN INTRACRANIAL HYPERTENSION 1/748 (0.1%) 0/480 (0%)
    CEREBRAL ARTERIOSCLEROSIS 0/748 (0%) 1/480 (0.2%)
    CEREBRAL ATROPHY 1/748 (0.1%) 0/480 (0%)
    CERVICAL MYELOPATHY 1/748 (0.1%) 0/480 (0%)
    COGNITIVE DISORDER 1/748 (0.1%) 0/480 (0%)
    COMA HEPATIC 1/748 (0.1%) 0/480 (0%)
    COMPLEX PARTIAL SEIZURES 1/748 (0.1%) 0/480 (0%)
    DEMENTIA ALZHEIMER'S TYPE 1/748 (0.1%) 0/480 (0%)
    DEMENTIA WITH LEWY BODIES 1/748 (0.1%) 0/480 (0%)
    ENCEPHALOPATHY 1/748 (0.1%) 0/480 (0%)
    HAEMORRHAGIC CEREBRAL INFARCTION 0/748 (0%) 1/480 (0.2%)
    HEPATIC ENCEPHALOPATHY 0/748 (0%) 1/480 (0.2%)
    HYDROCEPHALUS 0/748 (0%) 1/480 (0.2%)
    HYPERTENSIVE ENCEPHALOPATHY 1/748 (0.1%) 0/480 (0%)
    INTRACRANIAL HAEMATOMA 1/748 (0.1%) 0/480 (0%)
    LOSS OF CONSCIOUSNESS 0/748 (0%) 1/480 (0.2%)
    METABOLIC ENCEPHALOPATHY 0/748 (0%) 1/480 (0.2%)
    MUSCLE SPASTICITY 0/748 (0%) 1/480 (0.2%)
    NEURALGIA 1/748 (0.1%) 0/480 (0%)
    NEUROTOXICITY 0/748 (0%) 1/480 (0.2%)
    PARKINSON'S DISEASE 0/748 (0%) 1/480 (0.2%)
    PERIPHERAL SENSORIMOTOR NEUROPATHY 1/748 (0.1%) 0/480 (0%)
    POLYNEUROPATHY 1/748 (0.1%) 0/480 (0%)
    SENILE DEMENTIA 0/748 (0%) 1/480 (0.2%)
    SPONDYLITIC MYELOPATHY 1/748 (0.1%) 0/480 (0%)
    STUPOR 1/748 (0.1%) 0/480 (0%)
    SUBARACHNOID HAEMORRHAGE 0/748 (0%) 1/480 (0.2%)
    Psychiatric disorders
    MENTAL STATUS CHANGES 4/748 (0.5%) 5/480 (1%)
    CONFUSIONAL STATE 3/748 (0.4%) 1/480 (0.2%)
    ANXIETY 2/748 (0.3%) 1/480 (0.2%)
    DEPRESSION 1/748 (0.1%) 1/480 (0.2%)
    ACUTE PSYCHOSIS 1/748 (0.1%) 0/480 (0%)
    ANXIETY DISORDER 1/748 (0.1%) 0/480 (0%)
    BIPOLAR I DISORDER 1/748 (0.1%) 0/480 (0%)
    COMPLETED SUICIDE 1/748 (0.1%) 0/480 (0%)
    DELIRIUM 0/748 (0%) 1/480 (0.2%)
    DEPRESSION SUICIDAL 0/748 (0%) 1/480 (0.2%)
    DISORIENTATION 0/748 (0%) 1/480 (0.2%)
    MAJOR DEPRESSION 0/748 (0%) 1/480 (0.2%)
    MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION 1/748 (0.1%) 0/480 (0%)
    PSYCHOTIC DISORDER 1/748 (0.1%) 0/480 (0%)
    SUICIDE ATTEMPT 0/748 (0%) 1/480 (0.2%)
    Renal and urinary disorders
    RENAL FAILURE CHRONIC 22/748 (2.9%) 15/480 (3.1%)
    RENAL FAILURE ACUTE 4/748 (0.5%) 1/480 (0.2%)
    HAEMATURIA 1/748 (0.1%) 3/480 (0.6%)
    AZOTAEMIA 2/748 (0.3%) 1/480 (0.2%)
    CALCULUS URETERIC 0/748 (0%) 2/480 (0.4%)
    CYSTITIS HAEMORRHAGIC 1/748 (0.1%) 1/480 (0.2%)
    NEPHROLITHIASIS 1/748 (0.1%) 1/480 (0.2%)
    RENAL FAILURE 1/748 (0.1%) 1/480 (0.2%)
    RENAL IMPAIRMENT 2/748 (0.3%) 0/480 (0%)
    NEPHROPATHY TOXIC 1/748 (0.1%) 0/480 (0%)
    OBSTRUCTIVE UROPATHY 1/748 (0.1%) 0/480 (0%)
    PYELOCALIECTASIS 0/748 (0%) 1/480 (0.2%)
    RENAL CYST RUPTURED 1/748 (0.1%) 0/480 (0%)
    RENAL DISORDER 0/748 (0%) 1/480 (0.2%)
    RENAL HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    RENAL HYPERTENSION 0/748 (0%) 1/480 (0.2%)
    RENAL TUBULAR NECROSIS 0/748 (0%) 1/480 (0.2%)
    URINARY BLADDER POLYP 1/748 (0.1%) 0/480 (0%)
    Reproductive system and breast disorders
    BENIGN PROSTATIC HYPERPLASIA 1/748 (0.1%) 0/480 (0%)
    CERVIX INFLAMMATION 0/748 (0%) 1/480 (0.2%)
    CYSTOCELE 1/748 (0.1%) 0/480 (0%)
    GENITAL PROLAPSE 0/748 (0%) 1/480 (0.2%)
    OVARIAN CYST 0/748 (0%) 1/480 (0.2%)
    PROSTATISM 1/748 (0.1%) 0/480 (0%)
    PROSTATITIS 0/748 (0%) 1/480 (0.2%)
    TESTICULAR INFARCTION 0/748 (0%) 1/480 (0.2%)
    UTERINE CERVICAL SQUAMOUS METAPLASIA 0/748 (0%) 1/480 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    PULMONARY OEDEMA 9/748 (1.2%) 12/480 (2.5%)
    PLEURAL EFFUSION 10/748 (1.3%) 7/480 (1.5%)
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE 6/748 (0.8%) 5/480 (1%)
    DYSPNOEA 5/748 (0.7%) 3/480 (0.6%)
    RESPIRATORY FAILURE 6/748 (0.8%) 2/480 (0.4%)
    PNEUMONIA ASPIRATION 5/748 (0.7%) 2/480 (0.4%)
    ACUTE PULMONARY OEDEMA 3/748 (0.4%) 3/480 (0.6%)
    PULMONARY EMBOLISM 5/748 (0.7%) 1/480 (0.2%)
    ACUTE RESPIRATORY FAILURE 4/748 (0.5%) 0/480 (0%)
    NON-CARDIOGENIC PULMONARY OEDEMA 2/748 (0.3%) 2/480 (0.4%)
    PULMONARY HYPERTENSION 3/748 (0.4%) 1/480 (0.2%)
    ASTHMA 1/748 (0.1%) 2/480 (0.4%)
    EPISTAXIS 2/748 (0.3%) 1/480 (0.2%)
    HAEMOTHORAX 2/748 (0.3%) 1/480 (0.2%)
    BRONCHITIS CHRONIC 2/748 (0.3%) 0/480 (0%)
    HYPOXIA 1/748 (0.1%) 1/480 (0.2%)
    LUNG INFILTRATION 2/748 (0.3%) 0/480 (0%)
    ATELECTASIS 1/748 (0.1%) 0/480 (0%)
    BRONCHOSPASM 1/748 (0.1%) 0/480 (0%)
    CHOKING 1/748 (0.1%) 0/480 (0%)
    COUGH 1/748 (0.1%) 0/480 (0%)
    EMPHYSEMA 1/748 (0.1%) 0/480 (0%)
    HYDROTHORAX 0/748 (0%) 1/480 (0.2%)
    MEDIASTINAL HAEMORRHAGE 1/748 (0.1%) 0/480 (0%)
    PLEURITIC PAIN 1/748 (0.1%) 0/480 (0%)
    PNEUMONITIS 1/748 (0.1%) 0/480 (0%)
    PULMONARY FIBROSIS 1/748 (0.1%) 0/480 (0%)
    PULMONARY GRANULOMA 1/748 (0.1%) 0/480 (0%)
    PULMONARY HAEMORRHAGE 0/748 (0%) 1/480 (0.2%)
    PULMONARY VASCULITIS 1/748 (0.1%) 0/480 (0%)
    RESPIRATORY DISTRESS 0/748 (0%) 1/480 (0.2%)
    TRACHEAL ULCER 0/748 (0%) 1/480 (0.2%)
    UPPER RESPIRATORY TRACT INFLAMMATION 1/748 (0.1%) 0/480 (0%)
    WEGENER'S GRANULOMATOSIS 1/748 (0.1%) 0/480 (0%)
    Skin and subcutaneous tissue disorders
    SKIN ULCER 9/748 (1.2%) 3/480 (0.6%)
    ANGIOEDEMA 3/748 (0.4%) 0/480 (0%)
    DECUBITUS ULCER 2/748 (0.3%) 0/480 (0%)
    DRY GANGRENE 2/748 (0.3%) 0/480 (0%)
    DERMATITIS 1/748 (0.1%) 0/480 (0%)
    DIABETIC NEUROPATHIC ULCER 0/748 (0%) 1/480 (0.2%)
    DRUG ERUPTION 1/748 (0.1%) 0/480 (0%)
    LIPODYSTROPHY ACQUIRED 0/748 (0%) 1/480 (0.2%)
    PENILE ULCERATION 0/748 (0%) 1/480 (0.2%)
    SKIN DISORDER 1/748 (0.1%) 0/480 (0%)
    SKIN FISSURES 1/748 (0.1%) 0/480 (0%)
    Vascular disorders
    HYPOTENSION 12/748 (1.6%) 6/480 (1.3%)
    HYPERTENSION 9/748 (1.2%) 6/480 (1.3%)
    PERIPHERAL ISCHAEMIA 7/748 (0.9%) 6/480 (1.3%)
    DEEP VEIN THROMBOSIS 5/748 (0.7%) 2/480 (0.4%)
    PERIPHERAL VASCULAR DISORDER 4/748 (0.5%) 3/480 (0.6%)
    DIABETIC VASCULAR DISORDER 4/748 (0.5%) 2/480 (0.4%)
    PERIPHERAL ARTERIAL OCCLUSIVE DISEASE 4/748 (0.5%) 2/480 (0.4%)
    HYPERTENSIVE CRISIS 2/748 (0.3%) 3/480 (0.6%)
    ARTERIAL THROMBOSIS LIMB 4/748 (0.5%) 0/480 (0%)
    FEMORAL ARTERIAL STENOSIS 3/748 (0.4%) 1/480 (0.2%)
    AORTIC ANEURYSM RUPTURE 3/748 (0.4%) 0/480 (0%)
    ARTERIAL STENOSIS LIMB 1/748 (0.1%) 2/480 (0.4%)
    HYPERTENSIVE EMERGENCY 2/748 (0.3%) 1/480 (0.2%)
    ORTHOSTATIC HYPOTENSION 2/748 (0.3%) 1/480 (0.2%)
    VENOUS STENOSIS 1/748 (0.1%) 2/480 (0.4%)
    ACCELERATED HYPERTENSION 2/748 (0.3%) 0/480 (0%)
    AORTIC STENOSIS 1/748 (0.1%) 1/480 (0.2%)
    ARTERIAL STENOSIS 0/748 (0%) 2/480 (0.4%)
    ARTERIOSCLEROSIS 1/748 (0.1%) 1/480 (0.2%)
    ARTERIOSCLEROSIS OBLITERANS 2/748 (0.3%) 0/480 (0%)
    CIRCULATORY COLLAPSE 2/748 (0.3%) 0/480 (0%)
    EXTREMITY NECROSIS 2/748 (0.3%) 0/480 (0%)
    FEMORAL ARTERY OCCLUSION 2/748 (0.3%) 0/480 (0%)
    ILIAC ARTERY STENOSIS 1/748 (0.1%) 1/480 (0.2%)
    INTERMITTENT CLAUDICATION 0/748 (0%) 2/480 (0.4%)
    STEAL SYNDROME 1/748 (0.1%) 1/480 (0.2%)
    ANEURYSM 0/748 (0%) 1/480 (0.2%)
    ANEURYSM RUPTURED 0/748 (0%) 1/480 (0.2%)
    ANGIOPATHY 0/748 (0%) 1/480 (0.2%)
    AORTIC ANEURYSM 1/748 (0.1%) 0/480 (0%)
    AORTIC DISSECTION 0/748 (0%) 1/480 (0.2%)
    ARTERIAL DISORDER 1/748 (0.1%) 0/480 (0%)
    BRACHIOCEPHALIC VEIN STENOSIS 1/748 (0.1%) 0/480 (0%)
    FEMORAL ARTERY EMBOLISM 0/748 (0%) 1/480 (0.2%)
    HAEMATOMA 0/748 (0%) 1/480 (0.2%)
    HYPOVOLAEMIC SHOCK 0/748 (0%) 1/480 (0.2%)
    ISCHAEMIA 0/748 (0%) 1/480 (0.2%)
    JUGULAR VEIN THROMBOSIS 0/748 (0%) 1/480 (0.2%)
    MICROANGIOPATHY 0/748 (0%) 1/480 (0.2%)
    PERIPHERAL ARTERY ANEURYSM 1/748 (0.1%) 0/480 (0%)
    PHLEBITIS 1/748 (0.1%) 0/480 (0%)
    SUBCLAVIAN VEIN THROMBOSIS 1/748 (0.1%) 0/480 (0%)
    VASCULAR CALCIFICATION 1/748 (0.1%) 0/480 (0%)
    VASCULAR RUPTURE 1/748 (0.1%) 0/480 (0%)
    VASCULAR STENOSIS 0/748 (0%) 1/480 (0.2%)
    VASCULITIS 1/748 (0.1%) 0/480 (0%)
    VENA CAVA THROMBOSIS 1/748 (0.1%) 0/480 (0%)
    VENOUS INSUFFICIENCY 1/748 (0.1%) 0/480 (0%)
    VENOUS THROMBOSIS 1/748 (0.1%) 0/480 (0%)
    Other (Not Including Serious) Adverse Events
    Methoxy Polyethylene Glycol-Epoetin Beta Comparator ESA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 624/748 (83.4%) 390/480 (81.3%)
    Blood and lymphatic system disorders
    ANAEMIA 41/748 (5.5%) 25/480 (5.2%)
    Cardiac disorders
    ATRIAL FIBRILLATION 42/748 (5.6%) 30/480 (6.3%)
    Endocrine disorders
    HYPERPARATHYROIDISM SECONDARY 57/748 (7.6%) 44/480 (9.2%)
    Gastrointestinal disorders
    DIARRHOEA 141/748 (18.9%) 96/480 (20%)
    VOMITING 73/748 (9.8%) 44/480 (9.2%)
    NAUSEA 59/748 (7.9%) 41/480 (8.5%)
    CONSTIPATION 52/748 (7%) 41/480 (8.5%)
    ABDOMINAL PAIN 46/748 (6.1%) 22/480 (4.6%)
    ABDOMINAL PAIN UPPER 37/748 (4.9%) 27/480 (5.6%)
    General disorders
    PYREXIA 52/748 (7%) 27/480 (5.6%)
    Infections and infestations
    NASOPHARYNGITIS 107/748 (14.3%) 64/480 (13.3%)
    UPPER RESPIRATORY TRACT INFECTION 81/748 (10.8%) 63/480 (13.1%)
    URINARY TRACT INFECTION 77/748 (10.3%) 57/480 (11.9%)
    BRONCHITIS 75/748 (10%) 49/480 (10.2%)
    INFLUENZA 48/748 (6.4%) 23/480 (4.8%)
    GASTROENTERITIS 33/748 (4.4%) 27/480 (5.6%)
    Injury, poisoning and procedural complications
    PROCEDURAL HYPOTENSION 97/748 (13%) 56/480 (11.7%)
    ARTERIOVENOUS FISTULA SITE COMPLICATION 83/748 (11.1%) 36/480 (7.5%)
    ARTERIOVENOUS FISTULA THROMBOSIS 56/748 (7.5%) 24/480 (5%)
    ARTERIOVENOUS GRAFT THROMBOSIS 53/748 (7.1%) 26/480 (5.4%)
    CONTUSION 34/748 (4.5%) 27/480 (5.6%)
    VASCULAR GRAFT COMPLICATION 39/748 (5.2%) 22/480 (4.6%)
    Metabolism and nutrition disorders
    FLUID OVERLOAD 83/748 (11.1%) 38/480 (7.9%)
    HYPERKALAEMIA 47/748 (6.3%) 37/480 (7.7%)
    HYPERPHOSPHATAEMIA 47/748 (6.3%) 22/480 (4.6%)
    Musculoskeletal and connective tissue disorders
    MUSCLE SPASMS 75/748 (10%) 56/480 (11.7%)
    BACK PAIN 74/748 (9.9%) 44/480 (9.2%)
    PAIN IN EXTREMITY 76/748 (10.2%) 41/480 (8.5%)
    ARTHRALGIA 65/748 (8.7%) 42/480 (8.8%)
    MUSCULOSKELETAL PAIN 55/748 (7.4%) 30/480 (6.3%)
    OSTEOARTHRITIS 44/748 (5.9%) 24/480 (5%)
    Nervous system disorders
    HEADACHE 83/748 (11.1%) 43/480 (9%)
    Psychiatric disorders
    INSOMNIA 39/748 (5.2%) 33/480 (6.9%)
    DEPRESSION 38/748 (5.1%) 21/480 (4.4%)
    Renal and urinary disorders
    RENAL FAILURE CHRONIC 22/748 (2.9%) 28/480 (5.8%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 79/748 (10.6%) 58/480 (12.1%)
    DYSPNOEA 62/748 (8.3%) 41/480 (8.5%)
    Skin and subcutaneous tissue disorders
    PRURITUS 59/748 (7.9%) 35/480 (7.3%)
    Vascular disorders
    HYPERTENSION 167/748 (22.3%) 109/480 (22.7%)
    HYPOTENSION 31/748 (4.1%) 26/480 (5.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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 Medical Communications
    Organization Hoffmann-La Roche
    Phone 800-821-8590
    Email
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT00090753
    Other Study ID Numbers:
    • BH18387
    First Posted:
    Sep 6, 2004
    Last Update Posted:
    Feb 14, 2012
    Last Verified:
    Feb 1, 2012