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Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01301833
Collaborator
(none)
462
Enrollment
1
Location
4
Arms
19
Duration (Months)
24.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
462 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: teneligliptin

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )

Drug: teneligliptin
Other Names:
  • MP-513

    		•
    Experimental: teneligliptin and glinide

    teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide

    Drug: teneligliptin
    Other Names:
  • MP-513

    • Drug: glinide
    Experimental: teneligliptin and biguanide

    teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide

    Drug: teneligliptin
    Other Names:
  • MP-513

    • Drug: biguanide
    Experimental: teneligliptin and alpha-glucosidase inhibitor

    teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor

    Drug: teneligliptin
    Other Names:
  • MP-513

    • Drug: alpha-glucosidase inhibitor

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events [52 Weeks]

      Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.

    Secondary Outcome Measures

    1. Change From Baseline in HbA1c at Week 52 [Baseline and 52 weeks]

    2. Change From Baseline in Fasting Plasma Glucose at Week 52 [Baseline and 52 weeks]

    3. Change From Baseline in Fasting Glucagon at Week 52 [Baseline and 52 weeks]

    4. Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 [Baseline and 52 weeks]

    Eligibility Criteria

    Criteria

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

    • Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug

    • Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug

    • Patients whose HbA1c is between 6.5% - 10.0%

    • Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

    Exclusion Criteria:

    • Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)

    • Patients who are accepting treatments of arrhythmias

    • Patients with serious diabetic complications

    • Patients who are habitual excessive alcohol consumption.

    • Patients with severe hepatic disorder or severe renal disorder.

    • Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chitose-shi Hokkaidou Japan

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: Takashi Kadowaki, Professor, Tokyo University
    • Study Director: Kazuoki Kondo, MD, Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT01301833
    Other Study ID Numbers:
    • 3000-A14
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Nov 18, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Mitsubishi Tanabe Pharma Corporation
    insulin resistance
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Biguanides
    Glycoside Hydrolase Inhibitors

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Arm/Group Description teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
    Period Title: Overall Study
    STARTED 212 80 95 75
    COMPLETED 197 72 88 68
    NOT COMPLETED 15 8 7 7

    Baseline Characteristics

    Arm/Group Title Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor Total
    Arm/Group Description teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor Total of all reporting groups
    Overall Participants 212 80 95 75 462
    Age, Customized (participants) [Number]
    <65 years
    141
    66.5%
    45
    56.3%
    66
    69.5%
    39
    52%
    291
    63%
    >=65 years
    71
    33.5%
    35
    43.8%
    29
    30.5%
    36
    48%
    171
    37%
    Sex: Female, Male (Count of Participants)
    Female
    71
    33.5%
    31
    38.8%
    37
    38.9%
    25
    33.3%
    164
    35.5%
    Male
    141
    66.5%
    49
    61.3%
    58
    61.1%
    50
    66.7%
    298
    64.5%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events
    Description Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
    Time Frame 52 Weeks

    Outcome Measure Data

    Analysis Population Description
    Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.
    Arm/Group Title Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Arm/Group Description teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
    Measure Participants 212 80 95 75
    Serious Adverse Event
    14
    6.6%
    3
    3.8%
    6
    6.3%
    6
    8%
    Other Adverse Event
    182
    85.8%
    72
    90%
    81
    85.3%
    59
    78.7%
    2. Secondary Outcome
    Title Change From Baseline in HbA1c at Week 52
    Description
    Time Frame Baseline and 52 weeks

    Outcome Measure Data

    Analysis Population Description
    The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
    Arm/Group Title Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Arm/Group Description teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
    Measure Participants 212 80 95 75
    Mean (Standard Deviation) [Percent]
    -0.63
    (0.64)
    -0.76
    (0.70)
    -0.78
    (0.75)
    -0.89
    (0.64)
    3. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose at Week 52
    Description
    Time Frame Baseline and 52 weeks

    Outcome Measure Data

    Analysis Population Description
    The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
    Arm/Group Title Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Arm/Group Description teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
    Measure Participants 212 80 95 75
    Mean (Standard Deviation) [mg / dL]
    -11.7
    (25.5)
    -13.7
    (23.7)
    -12.7
    (27.1)
    -19.5
    (23.5)
    4. Secondary Outcome
    Title Change From Baseline in Fasting Glucagon at Week 52
    Description
    Time Frame Baseline and 52 weeks

    Outcome Measure Data

    Analysis Population Description
    The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
    Arm/Group Title Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Arm/Group Description teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
    Measure Participants 212 80 95 75
    Mean (Standard Deviation) [pg / mL]
    2.8
    (12.5)
    5.3
    (13.7)
    5.0
    (14.4)
    6.9
    (15.2)
    5. Secondary Outcome
    Title Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
    Description
    Time Frame Baseline and 52 weeks

    Outcome Measure Data

    Analysis Population Description
    The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
    Arm/Group Title Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Arm/Group Description teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
    Measure Participants 212 80 95 75
    Mean (Standard Deviation) [μU / mL]
    0.988
    (8.314)
    0.211
    (2.378)
    -0.173
    (9.093)
    -0.330
    (2.713)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Arm/Group Description teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
    All Cause Mortality
    Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/212 (6.6%) 3/80 (3.8%) 6/95 (6.3%) 6/75 (8%)
    Cardiac disorders
    Angina unstable 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Supraventricular tachycardia 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Congenital, familial and genetic disorders
    Ota's naevus 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Ear and labyrinth disorders
    Vertigo 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Endocrine disorders
    Thyroiditis 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Eye disorders
    Cataract 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Retinal detachment 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Gastrointestinal disorders
    Colonic polyp 1/212 (0.5%) 0/80 (0%) 1/95 (1.1%) 1/75 (1.3%)
    Enterocolitis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Haemorrhoids 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Ileus 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Inguinal hernia 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Mallory-Weiss syndrome 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Hepatobiliary disorders
    Bile duct stone 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Infections and infestations
    Cellulitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Injury, poisoning and procedural complications
    Upper limb fracture 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer 0/212 (0%) 0/80 (0%) 2/95 (2.1%) 0/75 (0%)
    Large intestine carcinoma 0/212 (0%) 0/80 (0%) 0/95 (0%) 2/75 (2.7%)
    Prostate cancer 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Thyroid cancer 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Uterine cancer 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Renal and urinary disorders
    Calculus ureteric 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Nephrolithiasis 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Respiratory, thoracic and mediastinal disorders
    Rhinitis hypertrophic 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Sleep apnoea syndrome 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Organising pneumonia 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Other (Not Including Serious) Adverse Events
    Teneligliptin Teneligliptin and Glinide Teneligliptin and Biguanide Teneligliptin and Alpha-glucosidase Inhibitor
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 182/212 (85.8%) 72/80 (90%) 81/95 (85.3%) 59/75 (78.7%)
    Cardiac disorders
    Aortic valve stenosis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 1/75 (1.3%)
    Supraventricular tachycardia 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Tachycardia 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Ear and labyrinth disorders
    Deafness neurosensory 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Meniere's disease 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Motion sickness 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Tinnitus 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Vertigo 1/212 (0.5%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Vertigo positional 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Deafness bilateral 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Endocrine disorders
    Hyperthyroidism 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Thyroid mass 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Eye disorders
    Asthenopia 4/212 (1.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Astigmatism 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Blepharitis 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Cataract 6/212 (2.8%) 2/80 (2.5%) 2/95 (2.1%) 0/75 (0%)
    Chalazion 0/212 (0%) 0/80 (0%) 2/95 (2.1%) 0/75 (0%)
    Conjunctival cyst 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Conjunctival deposit 1/212 (0.5%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Conjunctivitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Conjunctivitis allergic 4/212 (1.9%) 0/80 (0%) 0/95 (0%) 2/75 (2.7%)
    Diabetic retinopathy 1/212 (0.5%) 1/80 (1.3%) 2/95 (2.1%) 1/75 (1.3%)
    Dry eye 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Eye pain 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Iritis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Keratitis 2/212 (0.9%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Open angle glaucoma 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Punctate keratitis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Retinal detachment 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Retinal tear 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Pingueculitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Conjunctivochalasis 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Ulcerative keratitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Normal tension glaucoma 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 2/212 (0.9%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Abdominal distension 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Abdominal pain upper 4/212 (1.9%) 1/80 (1.3%) 2/95 (2.1%) 1/75 (1.3%)
    Cheilitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Colitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Colonic polyp 3/212 (1.4%) 2/80 (2.5%) 2/95 (2.1%) 0/75 (0%)
    Constipation 7/212 (3.3%) 2/80 (2.5%) 7/95 (7.4%) 2/75 (2.7%)
    Dental caries 2/212 (0.9%) 1/80 (1.3%) 2/95 (2.1%) 1/75 (1.3%)
    Diarrhoea 7/212 (3.3%) 0/80 (0%) 2/95 (2.1%) 4/75 (5.3%)
    Duodenal polyp 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Duodenal ulcer 1/212 (0.5%) 0/80 (0%) 1/95 (1.1%) 1/75 (1.3%)
    Duodenitis 0/212 (0%) 0/80 (0%) 2/95 (2.1%) 1/75 (1.3%)
    Dyspepsia 3/212 (1.4%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Enterocolitis 1/212 (0.5%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Flatulence 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Gastric polyps 2/212 (0.9%) 3/80 (3.8%) 0/95 (0%) 0/75 (0%)
    Gastric ulcer 1/212 (0.5%) 2/80 (2.5%) 0/95 (0%) 0/75 (0%)
    Gastritis 3/212 (1.4%) 2/80 (2.5%) 4/95 (4.2%) 3/75 (4%)
    Gastritis atrophic 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Gastritis erosive 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Gastrooesophageal reflux disease 2/212 (0.9%) 3/80 (3.8%) 4/95 (4.2%) 5/75 (6.7%)
    Gingivitis 1/212 (0.5%) 1/80 (1.3%) 1/95 (1.1%) 2/75 (2.7%)
    Haematemesis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Haemorrhoids 5/212 (2.4%) 1/80 (1.3%) 1/95 (1.1%) 1/75 (1.3%)
    Hiatus hernia 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Nausea 2/212 (0.9%) 1/80 (1.3%) 1/95 (1.1%) 1/75 (1.3%)
    Periodontal disease 1/212 (0.5%) 2/80 (2.5%) 1/95 (1.1%) 2/75 (2.7%)
    Periodontitis 7/212 (3.3%) 3/80 (3.8%) 3/95 (3.2%) 0/75 (0%)
    Rectal polyp 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Stomatitis 1/212 (0.5%) 2/80 (2.5%) 3/95 (3.2%) 1/75 (1.3%)
    Tooth loss 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Vomiting 1/212 (0.5%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Haemorrhagic erosive gastritis 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    General disorders
    Chills 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Feeling abnormal 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Local swelling 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Malaise 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Oedema peripheral 3/212 (1.4%) 0/80 (0%) 1/95 (1.1%) 1/75 (1.3%)
    Pyrexia 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Thirst 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Hepatobiliary disorders
    Cholecystitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Cholelithiasis 1/212 (0.5%) 0/80 (0%) 2/95 (2.1%) 0/75 (0%)
    Hepatic steatosis 2/212 (0.9%) 2/80 (2.5%) 3/95 (3.2%) 1/75 (1.3%)
    Gallbladder polyp 2/212 (0.9%) 1/80 (1.3%) 0/95 (0%) 1/75 (1.3%)
    Immune system disorders
    Seasonal allergy 1/212 (0.5%) 2/80 (2.5%) 1/95 (1.1%) 0/75 (0%)
    Infections and infestations
    Acute sinusitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Acute tonsillitis 1/212 (0.5%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Body tinea 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 1/75 (1.3%)
    Bronchitis 7/212 (3.3%) 7/80 (8.8%) 5/95 (5.3%) 2/75 (2.7%)
    Cellulitis orbital 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Cystitis 6/212 (2.8%) 1/80 (1.3%) 5/95 (5.3%) 2/75 (2.7%)
    Dermatitis infected 0/212 (0%) 2/80 (2.5%) 0/95 (0%) 0/75 (0%)
    Folliculitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Gastroenteritis 4/212 (1.9%) 3/80 (3.8%) 2/95 (2.1%) 1/75 (1.3%)
    Gastroenteritis viral 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Herpes simplex 1/212 (0.5%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Herpes zoster 3/212 (1.4%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Hordeolum 3/212 (1.4%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Influenza 3/212 (1.4%) 4/80 (5%) 3/95 (3.2%) 2/75 (2.7%)
    Mumps 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Nasopharyngitis 62/212 (29.2%) 19/80 (23.8%) 28/95 (29.5%) 21/75 (28%)
    Onychomycosis 4/212 (1.9%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Otitis externa 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Paronychia 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Pharyngitis 12/212 (5.7%) 4/80 (5%) 5/95 (5.3%) 1/75 (1.3%)
    Pneumonia 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Pneumonia mycoplasmal 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Pulpitis dental 1/212 (0.5%) 1/80 (1.3%) 1/95 (1.1%) 1/75 (1.3%)
    Pyelonephritis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Sinusitis 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 2/75 (2.7%)
    Subcutaneous abscess 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Tinea pedis 4/212 (1.9%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Tonsillitis 0/212 (0%) 1/80 (1.3%) 2/95 (2.1%) 0/75 (0%)
    Urethritis 0/212 (0%) 0/80 (0%) 0/95 (0%) 2/75 (2.7%)
    Urinary tract infection 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Vulvitis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Peritonsillitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Gingival abscess 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Helicobacter infection 1/212 (0.5%) 1/80 (1.3%) 0/95 (0%) 1/75 (1.3%)
    Enteritis infectious 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 1/75 (1.3%)
    Mycoplasma infection 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Dental gangrene 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Acarodermatitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Oral herpes 3/212 (1.4%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Injury, poisoning and procedural complications
    Animal bite 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Arthropod sting 3/212 (1.4%) 3/80 (3.8%) 2/95 (2.1%) 0/75 (0%)
    Bite 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Chillblains 3/212 (1.4%) 0/80 (0%) 0/95 (0%) 2/75 (2.7%)
    Epicondylitis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Hand fracture 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Ligament sprain 1/212 (0.5%) 2/80 (2.5%) 2/95 (2.1%) 0/75 (0%)
    Rib fracture 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Tendon rupture 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Ulna fracture 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Fractured coccyx 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Excoriation 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Muscle strain 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Contusion 10/212 (4.7%) 5/80 (6.3%) 4/95 (4.2%) 3/75 (4%)
    Thermal burn 1/212 (0.5%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Open wound 4/212 (1.9%) 0/80 (0%) 0/95 (0%) 4/75 (5.3%)
    Ligament injury 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Skeletal injury 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Tooth fracture 2/212 (0.9%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Heat illness 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 2/75 (2.7%)
    Post-traumatic neck syndrome 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Investigations
    Alanine aminotransferase increased 3/212 (1.4%) 0/80 (0%) 2/95 (2.1%) 3/75 (4%)
    Amylase increased 2/212 (0.9%) 2/80 (2.5%) 3/95 (3.2%) 1/75 (1.3%)
    Aspartate aminotransferase increased 2/212 (0.9%) 1/80 (1.3%) 2/95 (2.1%) 2/75 (2.7%)
    Blood bilirubin increased 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Blood cholesterol increased 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Blood creatine phosphokinase increased 12/212 (5.7%) 4/80 (5%) 6/95 (6.3%) 2/75 (2.7%)
    Blood lactate dehydrogenase increased 0/212 (0%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Blood potassium increased 2/212 (0.9%) 2/80 (2.5%) 0/95 (0%) 1/75 (1.3%)
    Blood pressure increased 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Blood triglycerides increased 2/212 (0.9%) 1/80 (1.3%) 2/95 (2.1%) 1/75 (1.3%)
    Blood urea increased 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Blood uric acid increased 3/212 (1.4%) 0/80 (0%) 2/95 (2.1%) 1/75 (1.3%)
    Gamma-glutamyltransferase increased 2/212 (0.9%) 1/80 (1.3%) 2/95 (2.1%) 1/75 (1.3%)
    Glucose urine present 10/212 (4.7%) 3/80 (3.8%) 7/95 (7.4%) 0/75 (0%)
    Blood urine present 15/212 (7.1%) 6/80 (7.5%) 9/95 (9.5%) 5/75 (6.7%)
    Haemoglobin decreased 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 1/75 (1.3%)
    Lipase increased 3/212 (1.4%) 1/80 (1.3%) 4/95 (4.2%) 2/75 (2.7%)
    Low density lipoprotein increased 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Prostatic specific antigen increased 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Protein urine present 14/212 (6.6%) 6/80 (7.5%) 4/95 (4.2%) 5/75 (6.7%)
    Urine ketone body present 7/212 (3.3%) 6/80 (7.5%) 6/95 (6.3%) 2/75 (2.7%)
    Blood alkaline phosphatase increased 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 2/75 (2.7%)
    Occult blood positive 0/212 (0%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Helicobacter test positive 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Metabolism and nutrition disorders
    Dehydration 1/212 (0.5%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Hyperuricaemia 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Hypoglycaemia 4/212 (1.9%) 4/80 (5%) 1/95 (1.1%) 1/75 (1.3%)
    Decreased appetite 1/212 (0.5%) 1/80 (1.3%) 0/95 (0%) 1/75 (1.3%)
    Hyperlipidaemia 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 7/212 (3.3%) 5/80 (6.3%) 2/95 (2.1%) 1/75 (1.3%)
    Arthritis 2/212 (0.9%) 0/80 (0%) 1/95 (1.1%) 1/75 (1.3%)
    Back pain 13/212 (6.1%) 2/80 (2.5%) 4/95 (4.2%) 4/75 (5.3%)
    Dupuytren's contracture 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Lumbar spinal stenosis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 1/75 (1.3%)
    Muscle spasms 5/212 (2.4%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Musculoskeletal pain 2/212 (0.9%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Myalgia 6/212 (2.8%) 2/80 (2.5%) 3/95 (3.2%) 2/75 (2.7%)
    Myositis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Neck pain 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Nodal osteoarthritis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Osteoarthritis 4/212 (1.9%) 2/80 (2.5%) 1/95 (1.1%) 0/75 (0%)
    Pain in extremity 4/212 (1.9%) 1/80 (1.3%) 2/95 (2.1%) 3/75 (4%)
    Periarthritis 4/212 (1.9%) 1/80 (1.3%) 3/95 (3.2%) 2/75 (2.7%)
    Plantar fasciitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Rheumatoid arthritis 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Spinal osteoarthritis 5/212 (2.4%) 2/80 (2.5%) 2/95 (2.1%) 0/75 (0%)
    Synovial cyst 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Synovitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Tenosynovitis 3/212 (1.4%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Trigger finger 2/212 (0.9%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Musculoskeletal stiffness 0/212 (0%) 2/80 (2.5%) 0/95 (0%) 0/75 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of liver 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Lipoma 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Seborrhoeic keratosis 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Thyroid neoplasm 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Uterine leiomyoma 3/212 (1.4%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Nervous system disorders
    Altered state of consciousness 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Carotid artery stenosis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Carpal tunnel syndrome 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Cervicobrachial syndrome 2/212 (0.9%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Diabetic neuropathy 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Dizziness 3/212 (1.4%) 3/80 (3.8%) 0/95 (0%) 1/75 (1.3%)
    Headache 5/212 (2.4%) 0/80 (0%) 2/95 (2.1%) 1/75 (1.3%)
    Hypoaesthesia 3/212 (1.4%) 1/80 (1.3%) 0/95 (0%) 1/75 (1.3%)
    Myelopathy 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Neuralgia 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Neuropathy peripheral 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Post herpetic neuralgia 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Sciatica 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Tremor 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Intercostal neuralgia 1/212 (0.5%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Carotid arteriosclerosis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Psychiatric disorders
    Depression 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Dysphoria 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Insomnia 2/212 (0.9%) 1/80 (1.3%) 2/95 (2.1%) 1/75 (1.3%)
    Sleep disorder 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Anxiety disorder 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Renal and urinary disorders
    Calculus bladder 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Calculus ureteric 2/212 (0.9%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Haematuria 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Hypertonic bladder 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    IgA nephropathy 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Nephrolithiasis 0/212 (0%) 0/80 (0%) 3/95 (3.2%) 1/75 (1.3%)
    Pollakiuria 1/212 (0.5%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Diabetic nephropathy 0/212 (0%) 0/80 (0%) 2/95 (2.1%) 0/75 (0%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Dysmenorrhoea 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Prostatitis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Pruritus genital 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 2/212 (0.9%) 2/80 (2.5%) 1/95 (1.1%) 1/75 (1.3%)
    Cough 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Rhinitis allergic 7/212 (3.3%) 1/80 (1.3%) 1/95 (1.1%) 1/75 (1.3%)
    Rhinorrhoea 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Sleep apnoea syndrome 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Sputum increased 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Tonsillar hypertrophy 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Upper respiratory tract inflammation 20/212 (9.4%) 11/80 (13.8%) 10/95 (10.5%) 8/75 (10.7%)
    Allergic pharyngitis 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Vocal cord disorder 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Oropharyngeal discomfort 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Oropharyngeal pain 0/212 (0%) 0/80 (0%) 2/95 (2.1%) 0/75 (0%)
    Skin and subcutaneous tissue disorders
    Acne 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Dandruff 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Dermal cyst 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Dermatitis 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Dermatitis allergic 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Dermatitis contact 4/212 (1.9%) 0/80 (0%) 3/95 (3.2%) 2/75 (2.7%)
    Dry skin 3/212 (1.4%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Dyshidrosis 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Eczema 8/212 (3.8%) 4/80 (5%) 1/95 (1.1%) 7/75 (9.3%)
    Eczema asteatotic 1/212 (0.5%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Heat rash 1/212 (0.5%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Hyperkeratosis 2/212 (0.9%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Ingrowing nail 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Photosensitivity reaction 0/212 (0%) 0/80 (0%) 1/95 (1.1%) 0/75 (0%)
    Prurigo 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Pruritus 1/212 (0.5%) 1/80 (1.3%) 2/95 (2.1%) 0/75 (0%)
    Rash 6/212 (2.8%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Skin exfoliation 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (0%)
    Urticaria 1/212 (0.5%) 1/80 (1.3%) 0/95 (0%) 1/75 (1.3%)
    Xeroderma 0/212 (0%) 0/80 (0%) 0/95 (0%) 1/75 (1.3%)
    Pruritus generalised 0/212 (0%) 0/80 (0%) 2/95 (2.1%) 0/75 (0%)
    Toxic skin eruption 0/212 (0%) 1/80 (1.3%) 1/95 (1.1%) 1/75 (1.3%)
    Skin mass 0/212 (0%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Vascular disorders
    Hypertension 2/212 (0.9%) 1/80 (1.3%) 1/95 (1.1%) 0/75 (0%)
    Orthostatic hypotension 3/212 (1.4%) 1/80 (1.3%) 0/95 (0%) 0/75 (0%)
    Peripheral coldness 1/212 (0.5%) 0/80 (0%) 0/95 (0%) 0/75 (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:
    NCT01301833
    Other Study ID Numbers:
    • 3000-A14
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Nov 18, 2015
    Last Verified:
    Oct 1, 2015