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A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00542386
Collaborator
(none)
642
Enrollment
73
Locations
2
Arms
23
Duration (Months)
8.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
642 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
Other Names:
  • Colestilan(INN),
  • Colestimide(JAN)
  • CHOLEBINE®
  • BindRen®

    		•
    Placebo Comparator: 2

    Drug: Placebo
    3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

    Outcome Measures

    Primary Outcome Measures

    1. The Change in Serum Phosphorus [12 weeks]

      The change from baseline to week 12

    2. The Change in LDL-cholesterol [12 weeks]

      The percentage change from baseline to week 12

    Secondary Outcome Measures

    1. The Change in Total-cholesterol [12 weeks]

    2. The Change in HDL-cholesterol [12 weeks]

    3. The Change in Triglycerides [12 weeks]

    4. The Change in PTH [12 weeks]

    5. The Change in Ca [12 weeks]

    6. The Change in Ca x P Ion Product [12 weeks]

    7. The Incidence of Adverse Events [12 weeks]

    Eligibility Criteria

    Criteria

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

    • Male or female, 18 years of age or over

    • Clinically stable haemodialysis or peritoneal dialysis

    • Stable phosphate control

    • On a stabilised phosphorus diet

    • Female and of child-bearing potential have a negative serum pregnancy test

    • Male subjects must agree to use appropriate contraception

    Exclusion Criteria:

    • Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.

    • A a serum albumin level<30.0g/L

    • A PTH level >1000pg/mL

    • A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡

    • A serum LDL-C level >4.94mmol/L(190mg/dL)

    • A serum triglycerides level >6.76mmol/L (600mg/dL)

    • A History of significant gastrointestinal motility problems

    • A positive test for HIV 1 and 2 antibodies

    • A history of substance or alcohol abuse within the last year

    • Seizure disorders

    • A history of drug or other allergy

    • A temporary catheter as a vascular access

    • Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ajka Hungary
    2 Baja Hungary
    3 Budapest Hungary
    4 Esztergom Hungary
    5 Gyor Hungary
    6 Hatvan Hungary
    7 Kisvarda Hungary
    8 Lecco Italy
    9 Modena Italy
    10 Pavia Italy
    11 Roma Italy
    12 Skopje Macedonia, The Former Yugoslav Republic of
    13 Alor Star Malaysia
    14 Ipoh Malaysia
    15 Kajang Malaysia
    16 Klang Malaysia
    17 Kota Kinabalu Malaysia
    18 Kuala Terengganu Malaysia
    19 Kuantan Malaysia
    20 Kuching Malaysia
    21 Melaka Malaysia
    22 Seremban Malaysia
    23 Taiping Malaysia
    24 Lodz Poland
    25 Plock Poland
    26 Poznan Poland
    27 Rybnik Poland
    28 Warszawa Poland
    29 Wroclaw Poland
    30 Zielona Gora Poland
    31 Arkhangelsk Russian Federation
    32 Armavir Russian Federation
    33 Chelyabinsk Russian Federation
    34 Chita Russian Federation
    35 Ekaterinburg Russian Federation
    36 Irkutsk Russian Federation
    37 Ivanovo Russian Federation
    38 Kaluga Russian Federation
    39 Kemerovo Russian Federation
    40 Khabarovsk Russian Federation
    41 Krasnodar Russian Federation
    42 Krasnoyarsk Russian Federation
    43 Moscow Russian Federation
    44 Nizhniy Novgorod Russian Federation
    45 Novokuznetsk Russian Federation
    46 Novorossiysk Russian Federation
    47 Novosibirsk Russian Federation
    48 Omsk Russian Federation
    49 Petrozavodsk Russian Federation
    50 Rostov-on Don Russian Federation
    51 Smolensk Russian Federation
    52 St. Petersburg Russian Federation
    53 Tomsk Russian Federation
    54 Tumen Russian Federation
    55 Tver Russian Federation
    56 Vladimir Russian Federation
    57 Vladivostok Russian Federation
    58 Volzhskiy Russian Federation
    59 Yaroslavl Russian Federation
    60 Belgrade Serbia
    61 Kragujevac Serbia
    62 NIS Serbia
    63 Novi Sad Serbia
    64 Chernivtsi Ukraine
    65 Dnepropetrovsk Ukraine
    66 Ivano-Frankivsk Ukraine
    67 Kharkiv Ukraine
    68 Kiev Ukraine
    69 Mykolaiv Ukraine
    70 Ternopil Ukraine
    71 Uzhgorod Ukraine
    72 Zaporizhya Ukraine
    73 Zhytomyr Ukraine

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Principal Investigator: Professor, Information at Mitsubishi Pharma Europe

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT00542386
    Other Study ID Numbers:
    • MCI-196-E08
    First Posted:
    Oct 11, 2007
    Last Update Posted:
    Oct 6, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Mitsubishi Tanabe Pharma Corporation
    Chronic Kidney Disease
    Dialysis
    Hyperphosphatemia
    Dyslipidemia
    Phosphate binder
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Dyslipidemias
    Hyperphosphatemia

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title MCI-196: 3 g MCI-196: 6 g MCI-196: 9 g MCI-196: 12 g MCI-196: 15 g Pooled Placebo
    Arm/Group Description MCI-196: 3 g/ day MCI-196: 6 g/ day MCI-196: 9 g/ day MCI-196: 12 g/ day MCI-196: 15 g/ day Placebo 9 tablets, 12 tablets and 15 tablets/ day
    Period Title: Overall Study
    STARTED 104 102 99 103 102 132
    COMPLETED 61 74 66 65 62 82
    NOT COMPLETED 43 28 33 38 40 50

    Baseline Characteristics

    Arm/Group Title MCI-196: 3 g MCI-196: 6 g MCI-196: 9 g MCI-196: 12 g MCI-196: 15 g Pooled Placebo Total
    Arm/Group Description MCI-196: 3 g/ day MCI-196: 6 g/ day MCI-196: 9 g/ day MCI-196: 12 g/ day MCI-196: 15 g/ day Placebo 9 tablets, 12 tablets and 15 tablets/ day Total of all reporting groups
    Overall Participants 104 102 98 102 101 132 639
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    49.9
    (12.20)
    48.7
    (14.64)
    47.3
    (12.55)
    49.5
    (12.41)
    50.7
    (11.34)
    48.5
    (12.54)
    49.1
    (12.65)
    Sex: Female, Male (Count of Participants)
    Female
    48
    46.2%
    54
    52.9%
    48
    49%
    48
    47.1%
    46
    45.5%
    55
    41.7%
    299
    46.8%
    Male
    56
    53.8%
    48
    47.1%
    50
    51%
    54
    52.9%
    55
    54.5%
    77
    58.3%
    340
    53.2%

    Outcome Measures

    1. Primary Outcome
    Title The Change in Serum Phosphorus
    Description The change from baseline to week 12
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start
    Arm/Group Title MCI-196: 3 g MCI-196: 6 g MCI-196: 9 g MCI-196: 12 g MCI-196: 15 g Pooled Placebo
    Arm/Group Description MCI-196: 3 g/ day MCI-196: 6 g/ day MCI-196: 9 g/ day MCI-196: 12 g/ day MCI-196: 15 g/ day Placebo 9 tablets, 12 tablets and 15 tablets/ day
    Measure Participants 104 101 97 100 99 130
    Mean (Standard Deviation) [mg/dL]
    -0.23
    (1.62)
    -0.77
    (1.97)
    -0.97
    (1.68)
    -0.71
    (1.84)
    -1.41
    (1.43)
    -0.12
    (1.70)
    2. Primary Outcome
    Title The Change in LDL-cholesterol
    Description The percentage change from baseline to week 12
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start of study medication.
    Arm/Group Title MCI-196: 3 g MCI-196: 6 g MCI-196: 9 g MCI-196: 12 g MCI-196: 15 g Pooled Placebo
    Arm/Group Description MCI-196: 3 g/ day MCI-196: 6 g/ day MCI-196: 9 g/ day MCI-196: 12 g/ day MCI-196: 15 g/ day Placebo 9 tablets, 12 tablets and 15 tablets/ day
    Measure Participants 104 101 97 100 99 130
    Mean (Standard Deviation) [Percent change]
    -16.66
    (20.05)
    -23.56
    (20.99)
    -27.64
    (21.45)
    -29.44
    (25.28)
    -27.46
    (24.57)
    2.77
    (17.44)
    3. Secondary Outcome
    Title The Change in Total-cholesterol
    Description
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    Title The Change in HDL-cholesterol
    Description
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Secondary Outcome
    Title The Change in Triglycerides
    Description
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    6. Secondary Outcome
    Title The Change in PTH
    Description
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    7. Secondary Outcome
    Title The Change in Ca
    Description
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    8. Secondary Outcome
    Title The Change in Ca x P Ion Product
    Description
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    9. Secondary Outcome
    Title The Incidence of Adverse Events
    Description
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame 12 weeks
    Adverse Event Reporting Description Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
    Arm/Group Title MCI-196: 3 g MCI-196: 6 g MCI-196: 9 g MCI-196: 12 g MCI-196: 15 g Pooled Placebo
    Arm/Group Description MCI-196: 3 g/ day MCI-196: 6 g/ day MCI-196: 9 g/ day MCI-196: 12 g/ day MCI-196: 15 g/ day Placebo 9 tablets, 12 tablets and 15 tablets/ day
    All Cause Mortality
    MCI-196: 3 g MCI-196: 6 g MCI-196: 9 g MCI-196: 12 g MCI-196: 15 g Pooled Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    MCI-196: 3 g MCI-196: 6 g MCI-196: 9 g MCI-196: 12 g MCI-196: 15 g Pooled Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/104 (2.9%) 1/102 (1%) 2/98 (2%) 7/102 (6.9%) 5/101 (5%) 8/132 (6.1%)
    Cardiac disorders
    Ischaemic cardiomyopathy 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Cardiovascular insufficiency 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Pericarditis 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Atrial fibrillation 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Eye disorders
    Iritis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Gastrointestinal disorders
    Ascites 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Nausea 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Vomiting 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Abdominal pain 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Retroperitoneal haematoma 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Haemorrhoids 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Gastrointestinal haemorrhage 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    General disorders
    Mass 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Catheter site phlebitis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Infections and infestations
    Pyelonephritis chronic 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Cellulitis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Upper respiratory tract infection 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Acute sinusitis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Abscess limb 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Sepsis 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Hepatitis B 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Injury, poisoning and procedural complications
    Arteriovenous fistula thrombosis 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Eye injury 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Shunt thrombosis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Kidney rupture 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Road traffic accident 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Procedural hypotension 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Nervous system disorders
    Haemorrhagic stroke 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 2/132 (1.5%)
    Renal and urinary disorders
    Azotaemia 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Renal failure chronic 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Choking 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Surgical and medical procedures
    Renal transplant 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Vascular disorders
    Hypertension 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Other (Not Including Serious) Adverse Events
    MCI-196: 3 g MCI-196: 6 g MCI-196: 9 g MCI-196: 12 g MCI-196: 15 g Pooled Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 47/104 (45.2%) 44/102 (43.1%) 49/98 (50%) 53/102 (52%) 59/101 (58.4%) 65/132 (49.2%)
    Blood and lymphatic system disorders
    Anaemia 1/104 (1%) 1/102 (1%) 0/98 (0%) 1/102 (1%) 2/101 (2%) 0/132 (0%)
    Haemorrhagic disorder 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Lymphadenopathy 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Cardiac disorders
    Congestive cardiomyopathy 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Myocardial ischaemia 1/104 (1%) 0/102 (0%) 1/98 (1%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Ventricular extrasystoles 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Supraventricular extrasystoles 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Aortic valve calcification 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Angina pectoris 0/104 (0%) 1/102 (1%) 0/98 (0%) 2/102 (2%) 0/101 (0%) 0/132 (0%)
    Tachycardia 0/104 (0%) 0/102 (0%) 1/98 (1%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Extrasystoles 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Palpitations 0/104 (0%) 0/102 (0%) 0/98 (0%) 2/102 (2%) 0/101 (0%) 0/132 (0%)
    Conduction disorder 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Bradycardia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 2/132 (1.5%)
    Atrioventricular block first degree 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Bundle branch block left 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 2/132 (1.5%)
    Arrhythmia supraventricular 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Ear and labyrinth disorders
    Vertigo 0/104 (0%) 1/102 (1%) 0/98 (0%) 1/102 (1%) 1/101 (1%) 0/132 (0%)
    Cerumen impaction 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Endocrine disorders
    Hyperparathyroidism 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Hyperparathyroidism secondary 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 1/101 (1%) 1/132 (0.8%)
    Parathyroid disorder 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Hyperthyroidism 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Eye disorders
    Conjunctivitis 0/104 (0%) 0/102 (0%) 1/98 (1%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Visual acuity reduced 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Eye haemorrhage 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Ocular hyperaemia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Myopia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Gastrointestinal disorders
    Toothache 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Diarrhoea 5/104 (4.8%) 5/102 (4.9%) 6/98 (6.1%) 4/102 (3.9%) 5/101 (5%) 7/132 (5.3%)
    Nausea 4/104 (3.8%) 9/102 (8.8%) 12/98 (12.2%) 19/102 (18.6%) 20/101 (19.8%) 0/132 (0%)
    Hyperchlorhydria 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Flatulence 1/104 (1%) 0/102 (0%) 1/98 (1%) 3/102 (2.9%) 1/101 (1%) 3/132 (2.3%)
    Abdominal pain 3/104 (2.9%) 2/102 (2%) 4/98 (4.1%) 1/102 (1%) 3/101 (3%) 1/132 (0.8%)
    Frequent bowel movements 2/104 (1.9%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Abdominal pain upper 1/104 (1%) 3/102 (2.9%) 0/98 (0%) 3/102 (2.9%) 6/101 (5.9%) 2/132 (1.5%)
    Dyspepsia 4/104 (3.8%) 8/102 (7.8%) 7/98 (7.1%) 5/102 (4.9%) 9/101 (8.9%) 1/132 (0.8%)
    Proctalgia 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Constipation 3/104 (2.9%) 1/102 (1%) 6/98 (6.1%) 0/102 (0%) 5/101 (5%) 2/132 (1.5%)
    Eructation 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Epigastric discomfort 1/104 (1%) 1/102 (1%) 0/98 (0%) 1/102 (1%) 1/101 (1%) 0/132 (0%)
    Irritable bowel syndrome 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Vomiting 2/104 (1.9%) 4/102 (3.9%) 8/98 (8.2%) 11/102 (10.8%) 6/101 (5.9%) 2/132 (1.5%)
    Abdominal discomfort 1/104 (1%) 2/102 (2%) 1/98 (1%) 1/102 (1%) 3/101 (3%) 2/132 (1.5%)
    Dry mouth 2/104 (1.9%) 0/102 (0%) 2/98 (2%) 1/102 (1%) 2/101 (2%) 4/132 (3%)
    Odynophagia 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Abnormal faeces 1/104 (1%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Dyschezia 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Faecaloma 1/104 (1%) 1/102 (1%) 0/98 (0%) 2/102 (2%) 0/101 (0%) 2/132 (1.5%)
    Faeces discoloured 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Infrequent bowel movements 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Retching 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Gastritis 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 2/132 (1.5%)
    Abdominal distension 0/104 (0%) 3/102 (2.9%) 2/98 (2%) 7/102 (6.9%) 6/101 (5.9%) 4/132 (3%)
    Gastritis erosive 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 3/101 (3%) 0/132 (0%)
    Painful defaecation 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Peritonitis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Gastrointestinal hypermotility 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Defaecation urgency 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Faeces pale 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Haemorrhoidal haemorrhage 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Haemorrhoids 0/104 (0%) 0/102 (0%) 0/98 (0%) 2/102 (2%) 0/101 (0%) 0/132 (0%)
    Diarrhoea haemorrhagic 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Gastric disorder 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Dysphagia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Gastrointestinal pain 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Gastric ulcer 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Abdominal rigidity 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Duodenal ulcer 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Erosive oesophagitis 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Tongue disorder 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Duodenitis 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Gastrointestinal sounds abnormal 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Gastrointestinal motility disorder 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    General disorders
    Asthenia 4/104 (3.8%) 1/102 (1%) 3/98 (3.1%) 3/102 (2.9%) 4/101 (4%) 1/132 (0.8%)
    Pyrexia 4/104 (3.8%) 1/102 (1%) 1/98 (1%) 0/102 (0%) 1/101 (1%) 1/132 (0.8%)
    Chills 2/104 (1.9%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Chest discomfort 1/104 (1%) 0/102 (0%) 2/98 (2%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Malaise 0/104 (0%) 2/102 (2%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Oedema peripheral 0/104 (0%) 1/102 (1%) 0/98 (0%) 1/102 (1%) 1/101 (1%) 0/132 (0%)
    Pain 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Thirst 0/104 (0%) 1/102 (1%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 1/132 (0.8%)
    Fatigue 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Catheter related complication 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Non-cardiac chest pain 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Hepatobiliary disorders
    Hepatic cirrhosis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Hepatitis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Cholelithiasis 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Hepatitis toxic 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Biliary colic 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Immune system disorders
    Hypersensitivity 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Drug hypersensitivity 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Kidney transplant rejection 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Infections and infestations
    Breast abscess 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Injection site abscess 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Urinary tract infection 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Upper respiratory tract infection 1/104 (1%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 1/101 (1%) 1/132 (0.8%)
    Bacterial infection 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Varicella 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Gastroenteritis 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Laryngitis 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Nasopharyngitis 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Cystitis 0/104 (0%) 1/102 (1%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Cellulitis 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Bronchitis 0/104 (0%) 1/102 (1%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 2/132 (1.5%)
    Vaginitis bacterial 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Cervicitis 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Salpingo-oophoritis 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Influenza 0/104 (0%) 0/102 (0%) 2/98 (2%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Pharyngitis 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Sinusitis 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Respiratory tract infection 0/104 (0%) 0/102 (0%) 1/98 (1%) 1/102 (1%) 2/101 (2%) 2/132 (1.5%)
    Helicobacter infection 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Herpes zoster 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Pulmonary tuberculosis 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Respiratory tract infection viral 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 3/132 (2.3%)
    Oesophageal candidiasis 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Hepatitis C 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Viral infection 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Injury, poisoning and procedural complications
    Haemodialysis-induced symptom 2/104 (1.9%) 2/102 (2%) 0/98 (0%) 1/102 (1%) 2/101 (2%) 2/132 (1.5%)
    Procedural hypotension 2/104 (1.9%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 2/132 (1.5%)
    Contusion 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Traumatic haematoma 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Procedural hypertension 0/104 (0%) 0/102 (0%) 3/98 (3.1%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Extensive interdialytic weight gain 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Operative haemorrhage 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Arteriovenous fistula thrombosis 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 1/101 (1%) 0/132 (0%)
    Fall 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Ear injury 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Arteriovenous fistula site complication 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Thermal burn 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Investigations
    Blood parathyroid hormone increased 2/104 (1.9%) 1/102 (1%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 3/132 (2.3%)
    Blood pressure increased 2/104 (1.9%) 1/102 (1%) 0/98 (0%) 2/102 (2%) 0/101 (0%) 0/132 (0%)
    Weight increased 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Weight decreased 1/104 (1%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 2/101 (2%) 1/132 (0.8%)
    Blood phosphorus increased 3/104 (2.9%) 0/102 (0%) 1/98 (1%) 1/102 (1%) 0/101 (0%) 3/132 (2.3%)
    Cardiac murmur 1/104 (1%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Body temperature increased 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Aspartate aminotransferase increased 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Blood creatine phosphokinase increased 1/104 (1%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Gamma-glutamyltransferase increased 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Carotid bruit 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Blood alkaline phosphatase increased 0/104 (0%) 0/102 (0%) 2/98 (2%) 1/102 (1%) 1/101 (1%) 0/132 (0%)
    Blood pressure decreased 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Heart rate increased 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    ECG signs of myocardial ischaemia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Blood calcium decreased 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Blood phosphorus decreased 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Metabolism and nutrition disorders
    Hyperphosphataemia 3/104 (2.9%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Decreased appetite 2/104 (1.9%) 1/102 (1%) 1/98 (1%) 6/102 (5.9%) 4/101 (4%) 1/132 (0.8%)
    Cachexia 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Polydipsia 1/104 (1%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Hyperkalaemia 1/104 (1%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 3/132 (2.3%)
    Hypocalcaemia 2/104 (1.9%) 2/102 (2%) 3/98 (3.1%) 6/102 (5.9%) 2/101 (2%) 3/132 (2.3%)
    Fluid retention 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 1/132 (0.8%)
    Hyperlipidaemia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Abnormal weight gain 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Appetite disorder 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Increased appetite 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Musculoskeletal and connective tissue disorders
    Arthritis 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Neck pain 1/104 (1%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Pain in extremity 1/104 (1%) 1/102 (1%) 0/98 (0%) 2/102 (2%) 1/101 (1%) 2/132 (1.5%)
    Muscle spasms 2/104 (1.9%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 1/101 (1%) 2/132 (1.5%)
    Arthralgia 2/104 (1.9%) 0/102 (0%) 2/98 (2%) 1/102 (1%) 1/101 (1%) 5/132 (3.8%)
    Bone pain 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Pain in jaw 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Back pain 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Musculoskeletal pain 0/104 (0%) 0/102 (0%) 1/98 (1%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Myalgia 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Arthropathy 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Osteochondrosis 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroadenoma of breast 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Nervous system disorders
    Headache 3/104 (2.9%) 1/102 (1%) 2/98 (2%) 4/102 (3.9%) 0/101 (0%) 4/132 (3%)
    Hypertonia 1/104 (1%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Hypotonia 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Intercostal neuralgia 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Tremor 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Uraemic neuropathy 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Paraesthesia 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 1/132 (0.8%)
    Convulsions local 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Encephalopathy 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Dizziness 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 2/101 (2%) 1/132 (0.8%)
    Dysgeusia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Somnolence 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Parosmia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Tonic convulsion 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Polyneuropathy 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Trigeminal neuralgia 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Psychiatric disorders
    Sleep disorder 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Insomnia 0/104 (0%) 1/102 (1%) 1/98 (1%) 1/102 (1%) 1/101 (1%) 2/132 (1.5%)
    Anxiety 0/104 (0%) 0/102 (0%) 2/98 (2%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Hallucination, auditory 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Decreased activity 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Emotional distress 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Reproductive system and breast disorders
    Menorrhagia 0/104 (0%) 2/102 (2%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Oligomenorrhoea 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Breast pain 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Epistaxis 2/104 (1.9%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 4/132 (3%)
    Cough 1/104 (1%) 0/102 (0%) 2/98 (2%) 1/102 (1%) 1/101 (1%) 1/132 (0.8%)
    Throat irritation 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Asthma 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Rhinitis allergic 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Oropharyngeal pain 0/104 (0%) 0/102 (0%) 0/98 (0%) 2/102 (2%) 0/101 (0%) 0/132 (0%)
    Nasal dryness 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Skin and subcutaneous tissue disorders
    Rash pruritic 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Pruritus 3/104 (2.9%) 1/102 (1%) 2/98 (2%) 3/102 (2.9%) 1/101 (1%) 4/132 (3%)
    Alopecia 0/104 (0%) 0/102 (0%) 2/98 (2%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Cutaneous vasculitis 0/104 (0%) 0/102 (0%) 1/98 (1%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Rash papular 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Dermatitis allergic 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 1/132 (0.8%)
    Erythema 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 1/132 (0.8%)
    Cutaneous lupus erythematosus 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Dry skin 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 1/132 (0.8%)
    Surgical and medical procedures
    Renal transplant 1/104 (1%) 1/102 (1%) 1/98 (1%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Nephrectomy 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Vascular disorders
    Hypertensive crisis 1/104 (1%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Hypotension 1/104 (1%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)
    Hypertension 3/104 (2.9%) 6/102 (5.9%) 6/98 (6.1%) 2/102 (2%) 5/101 (5%) 4/132 (3%)
    Aortic stenosis 0/104 (0%) 1/102 (1%) 0/98 (0%) 0/102 (0%) 0/101 (0%) 0/132 (0%)
    Haematoma 0/104 (0%) 0/102 (0%) 0/98 (0%) 3/102 (2.9%) 0/101 (0%) 0/132 (0%)
    Blood pressure fluctuation 0/104 (0%) 0/102 (0%) 0/98 (0%) 1/102 (1%) 0/101 (0%) 0/132 (0%)
    Arteriosclerosis obliterans 0/104 (0%) 0/102 (0%) 0/98 (0%) 0/102 (0%) 1/101 (1%) 0/132 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Results Point of Contact

    Name/Title Clinical Trials, Information Desk
    Organization Mitsubishi Tanabe Pharma Corporation
    Phone
    Email cti-inq-ml@ml.mt-pharma.co.jp
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT00542386
    Other Study ID Numbers:
    • MCI-196-E08
    First Posted:
    Oct 11, 2007
    Last Update Posted:
    Oct 6, 2014
    Last Verified:
    Sep 1, 2014