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Trial Outcomes & Findings for Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes (NCT NCT01301833)

NCT ID: NCT01301833

Last Updated: 2026-01-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

462 participants

Primary outcome timeframe

52 Weeks

Results posted on

2026-01-02

Participant Flow

Participant milestones

Participant milestones
Measure
Teneligliptin
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Teneligliptin and Glinide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin and Alpha-glucosidase Inhibitor
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Overall Study
STARTED
212
80
95
75
Overall Study
COMPLETED
197
72
88
68
Overall Study
NOT COMPLETED
15
8
7
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Teneligliptin
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Teneligliptin and Glinide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin and Alpha-glucosidase Inhibitor
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Overall Study
Physician Decision
3
1
1
0
Overall Study
Adverse Event
7
5
5
5
Overall Study
Lack of Efficacy
1
1
0
0
Overall Study
Withdrawal by Subject
3
1
1
2
Overall Study
Personal matter
1
0
0
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Teneligliptin
n=212 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Teneligliptin and Glinide
n=80 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
n=95 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin and Alpha-glucosidase Inhibitor
n=75 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Total
n=462 Participants
Total of all reporting groups
Age, Customized
<65 years
141 participants
n=228 Participants
45 participants
n=115 Participants
66 participants
n=343 Participants
39 participants
n=18 Participants
291 participants
n=89 Participants
Age, Customized
>=65 years
71 participants
n=228 Participants
35 participants
n=115 Participants
29 participants
n=343 Participants
36 participants
n=18 Participants
171 participants
n=89 Participants
Sex: Female, Male
Female
71 Participants
n=228 Participants
31 Participants
n=115 Participants
37 Participants
n=343 Participants
25 Participants
n=18 Participants
164 Participants
n=89 Participants
Sex: Female, Male
Male
141 Participants
n=228 Participants
49 Participants
n=115 Participants
58 Participants
n=343 Participants
50 Participants
n=18 Participants
298 Participants
n=89 Participants

PRIMARY outcome

Timeframe: 52 Weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Teneligliptin and Alpha-glucosidase Inhibitor
n=75 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Teneligliptin and Glinide
n=80 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
n=95 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin
n=212 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Number of Participants With Adverse Events
Serious Adverse Event
6 participants
3 participants
6 participants
14 participants
Number of Participants With Adverse Events
Other Adverse Event
59 participants
72 participants
81 participants
182 participants

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: 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.

Outcome measures

Outcome measures
Measure
Teneligliptin and Alpha-glucosidase Inhibitor
n=75 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Teneligliptin and Glinide
n=80 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
n=95 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin
n=212 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Change From Baseline in HbA1c at Week 52
-0.89 Percent
Standard Deviation 0.64
-0.76 Percent
Standard Deviation 0.70
-0.78 Percent
Standard Deviation 0.75
-0.63 Percent
Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: 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.

Outcome measures

Outcome measures
Measure
Teneligliptin and Alpha-glucosidase Inhibitor
n=75 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Teneligliptin and Glinide
n=80 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
n=95 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin
n=212 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Change From Baseline in Fasting Plasma Glucose at Week 52
-19.5 mg / dL
Standard Deviation 23.5
-13.7 mg / dL
Standard Deviation 23.7
-12.7 mg / dL
Standard Deviation 27.1
-11.7 mg / dL
Standard Deviation 25.5

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: 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.

Outcome measures

Outcome measures
Measure
Teneligliptin and Alpha-glucosidase Inhibitor
n=75 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Teneligliptin and Glinide
n=80 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
n=95 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin
n=212 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Change From Baseline in Fasting Glucagon at Week 52
6.9 pg / mL
Standard Deviation 15.2
5.3 pg / mL
Standard Deviation 13.7
5.0 pg / mL
Standard Deviation 14.4
2.8 pg / mL
Standard Deviation 12.5

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: 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.

Outcome measures

Outcome measures
Measure
Teneligliptin and Alpha-glucosidase Inhibitor
n=75 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Teneligliptin and Glinide
n=80 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
n=95 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin
n=212 Participants
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
-0.330 μU / mL
Standard Deviation 2.713
0.211 μU / mL
Standard Deviation 2.378
-0.173 μU / mL
Standard Deviation 9.093
0.988 μU / mL
Standard Deviation 8.314

Adverse Events

Teneligliptin

Serious events: 14 serious events
Other events: 182 other events
Deaths: 0 deaths

Teneligliptin and Glinide

Serious events: 3 serious events
Other events: 72 other events
Deaths: 0 deaths

Teneligliptin and Biguanide

Serious events: 6 serious events
Other events: 81 other events
Deaths: 0 deaths

Teneligliptin and Alpha-glucosidase Inhibitor

Serious events: 6 serious events
Other events: 59 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Teneligliptin
n=212 participants at risk
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Teneligliptin and Glinide
n=80 participants at risk
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
n=95 participants at risk
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin and Alpha-glucosidase Inhibitor
n=75 participants at risk
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Colonic polyp
0.47%
1/212
0.00%
0/80
1.1%
1/95
1.3%
1/75
Gastrointestinal disorders
Enterocolitis
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Haemorrhoids
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Gastrointestinal disorders
Ileus
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Inguinal hernia
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Mallory-Weiss syndrome
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Hepatobiliary disorders
Bile duct stone
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Renal and urinary disorders
Calculus ureteric
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Renal and urinary disorders
Nephrolithiasis
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Congenital, familial and genetic disorders
Ota's naevus
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Cellulitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
0.00%
0/212
0.00%
0/80
2.1%
2/95
0.00%
0/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
0.00%
0/212
0.00%
0/80
0.00%
0/95
2.7%
2/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Endocrine disorders
Thyroiditis
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Eye disorders
Cataract
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Retinal detachment
0.94%
2/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Ear and labyrinth disorders
Vertigo
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Cardiac disorders
Angina unstable
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Cardiac disorders
Supraventricular tachycardia
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75

Other adverse events

Other adverse events
Measure
Teneligliptin
n=212 participants at risk
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Teneligliptin and Glinide
n=80 participants at risk
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Teneligliptin and Biguanide
n=95 participants at risk
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Teneligliptin and Alpha-glucosidase Inhibitor
n=75 participants at risk
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Infections and infestations
Subcutaneous abscess
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Infections and infestations
Tinea pedis
1.9%
4/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Infections and infestations
Tonsillitis
0.00%
0/212
1.2%
1/80
2.1%
2/95
0.00%
0/75
Infections and infestations
Urethritis
0.00%
0/212
0.00%
0/80
0.00%
0/95
2.7%
2/75
Infections and infestations
Urinary tract infection
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Infections and infestations
Vulvitis
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Peritonsillitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Gingival abscess
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Helicobacter infection
0.47%
1/212
1.2%
1/80
0.00%
0/95
1.3%
1/75
Infections and infestations
Enteritis infectious
0.00%
0/212
1.2%
1/80
0.00%
0/95
1.3%
1/75
Infections and infestations
Mycoplasma infection
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Infections and infestations
Dental gangrene
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Acarodermatitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Oral herpes
1.4%
3/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
1.4%
3/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Immune system disorders
Seasonal allergy
0.47%
1/212
2.5%
2/80
1.1%
1/95
0.00%
0/75
Endocrine disorders
Hyperthyroidism
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Endocrine disorders
Thyroid mass
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Metabolism and nutrition disorders
Dehydration
0.47%
1/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Metabolism and nutrition disorders
Hyperuricaemia
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Metabolism and nutrition disorders
Hypoglycaemia
1.9%
4/212
5.0%
4/80
1.1%
1/95
1.3%
1/75
Metabolism and nutrition disorders
Decreased appetite
0.47%
1/212
1.2%
1/80
0.00%
0/95
1.3%
1/75
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Psychiatric disorders
Depression
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Psychiatric disorders
Dysphoria
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Psychiatric disorders
Insomnia
0.94%
2/212
1.2%
1/80
2.1%
2/95
1.3%
1/75
Psychiatric disorders
Sleep disorder
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Psychiatric disorders
Anxiety disorder
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Altered state of consciousness
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Nervous system disorders
Carotid artery stenosis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Carpal tunnel syndrome
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Cervicobrachial syndrome
0.94%
2/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Diabetic neuropathy
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Dizziness
1.4%
3/212
3.8%
3/80
0.00%
0/95
1.3%
1/75
Nervous system disorders
Headache
2.4%
5/212
0.00%
0/80
2.1%
2/95
1.3%
1/75
Nervous system disorders
Hypoaesthesia
1.4%
3/212
1.2%
1/80
0.00%
0/95
1.3%
1/75
Nervous system disorders
Myelopathy
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Nervous system disorders
Neuralgia
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Neuropathy peripheral
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Post herpetic neuralgia
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Sciatica
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Tremor
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Nervous system disorders
Intercostal neuralgia
0.47%
1/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Nervous system disorders
Carotid arteriosclerosis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Asthenopia
1.9%
4/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Astigmatism
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Blepharitis
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Eye disorders
Cataract
2.8%
6/212
2.5%
2/80
2.1%
2/95
0.00%
0/75
Eye disorders
Chalazion
0.00%
0/212
0.00%
0/80
2.1%
2/95
0.00%
0/75
Eye disorders
Conjunctival cyst
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Eye disorders
Conjunctival deposit
0.47%
1/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Eye disorders
Conjunctivitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Conjunctivitis allergic
1.9%
4/212
0.00%
0/80
0.00%
0/95
2.7%
2/75
Eye disorders
Diabetic retinopathy
0.47%
1/212
1.2%
1/80
2.1%
2/95
1.3%
1/75
Eye disorders
Dry eye
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Eye disorders
Eye pain
0.94%
2/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Iritis
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Eye disorders
Keratitis
0.94%
2/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Eye disorders
Open angle glaucoma
0.94%
2/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Punctate keratitis
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Eye disorders
Retinal detachment
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Eye disorders
Retinal tear
0.94%
2/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Eye disorders
Pingueculitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Conjunctivochalasis
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Eye disorders
Ulcerative keratitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Eye disorders
Normal tension glaucoma
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Ear and labyrinth disorders
Deafness neurosensory
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Ear and labyrinth disorders
Meniere's disease
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Ear and labyrinth disorders
Motion sickness
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Ear and labyrinth disorders
Tinnitus
0.94%
2/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Ear and labyrinth disorders
Vertigo
0.47%
1/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Ear and labyrinth disorders
Vertigo positional
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Ear and labyrinth disorders
Deafness bilateral
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Cardiac disorders
Aortic valve stenosis
0.00%
0/212
1.2%
1/80
0.00%
0/95
1.3%
1/75
Cardiac disorders
Supraventricular tachycardia
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Cardiac disorders
Tachycardia
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Vascular disorders
Hypertension
0.94%
2/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Vascular disorders
Orthostatic hypotension
1.4%
3/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Vascular disorders
Peripheral coldness
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Asthma
0.94%
2/212
2.5%
2/80
1.1%
1/95
1.3%
1/75
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
3.3%
7/212
1.2%
1/80
1.1%
1/95
1.3%
1/75
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
0.47%
1/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Respiratory, thoracic and mediastinal disorders
Sputum increased
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
9.4%
20/212
13.8%
11/80
10.5%
10/95
10.7%
8/75
Respiratory, thoracic and mediastinal disorders
Allergic pharyngitis
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/212
0.00%
0/80
2.1%
2/95
0.00%
0/75
Gastrointestinal disorders
Abdominal discomfort
0.94%
2/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Gastrointestinal disorders
Abdominal distension
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Gastrointestinal disorders
Abdominal pain upper
1.9%
4/212
1.2%
1/80
2.1%
2/95
1.3%
1/75
Gastrointestinal disorders
Cheilitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Colitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Colonic polyp
1.4%
3/212
2.5%
2/80
2.1%
2/95
0.00%
0/75
Gastrointestinal disorders
Constipation
3.3%
7/212
2.5%
2/80
7.4%
7/95
2.7%
2/75
Gastrointestinal disorders
Dental caries
0.94%
2/212
1.2%
1/80
2.1%
2/95
1.3%
1/75
Gastrointestinal disorders
Diarrhoea
3.3%
7/212
0.00%
0/80
2.1%
2/95
5.3%
4/75
Gastrointestinal disorders
Duodenal polyp
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Gastrointestinal disorders
Duodenal ulcer
0.47%
1/212
0.00%
0/80
1.1%
1/95
1.3%
1/75
Gastrointestinal disorders
Duodenitis
0.00%
0/212
0.00%
0/80
2.1%
2/95
1.3%
1/75
Gastrointestinal disorders
Dyspepsia
1.4%
3/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Gastrointestinal disorders
Enterocolitis
0.47%
1/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Gastrointestinal disorders
Flatulence
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Gastric polyps
0.94%
2/212
3.8%
3/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Gastric ulcer
0.47%
1/212
2.5%
2/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Gastritis
1.4%
3/212
2.5%
2/80
4.2%
4/95
4.0%
3/75
Gastrointestinal disorders
Gastritis atrophic
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Gastrointestinal disorders
Gastritis erosive
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.94%
2/212
3.8%
3/80
4.2%
4/95
6.7%
5/75
Gastrointestinal disorders
Gingivitis
0.47%
1/212
1.2%
1/80
1.1%
1/95
2.7%
2/75
Gastrointestinal disorders
Haematemesis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Haemorrhoids
2.4%
5/212
1.2%
1/80
1.1%
1/95
1.3%
1/75
Gastrointestinal disorders
Hiatus hernia
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Gastrointestinal disorders
Nausea
0.94%
2/212
1.2%
1/80
1.1%
1/95
1.3%
1/75
Gastrointestinal disorders
Periodontal disease
0.47%
1/212
2.5%
2/80
1.1%
1/95
2.7%
2/75
Gastrointestinal disorders
Periodontitis
3.3%
7/212
3.8%
3/80
3.2%
3/95
0.00%
0/75
Gastrointestinal disorders
Rectal polyp
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Gastrointestinal disorders
Stomatitis
0.47%
1/212
2.5%
2/80
3.2%
3/95
1.3%
1/75
Gastrointestinal disorders
Tooth loss
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Gastrointestinal disorders
Vomiting
0.47%
1/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Gastrointestinal disorders
Haemorrhagic erosive gastritis
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Hepatobiliary disorders
Cholecystitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Hepatobiliary disorders
Cholelithiasis
0.47%
1/212
0.00%
0/80
2.1%
2/95
0.00%
0/75
Hepatobiliary disorders
Hepatic steatosis
0.94%
2/212
2.5%
2/80
3.2%
3/95
1.3%
1/75
Hepatobiliary disorders
Gallbladder polyp
0.94%
2/212
1.2%
1/80
0.00%
0/95
1.3%
1/75
Skin and subcutaneous tissue disorders
Acne
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Dandruff
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Dermal cyst
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Dermatitis
0.94%
2/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.94%
2/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Dermatitis contact
1.9%
4/212
0.00%
0/80
3.2%
3/95
2.7%
2/75
Skin and subcutaneous tissue disorders
Dry skin
1.4%
3/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Dyshidrosis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Eczema
3.8%
8/212
5.0%
4/80
1.1%
1/95
9.3%
7/75
Skin and subcutaneous tissue disorders
Eczema asteatotic
0.47%
1/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Heat rash
0.47%
1/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.94%
2/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Skin and subcutaneous tissue disorders
Ingrowing nail
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Photosensitivity reaction
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Prurigo
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Pruritus
0.47%
1/212
1.2%
1/80
2.1%
2/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Rash
2.8%
6/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Skin exfoliation
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Urticaria
0.47%
1/212
1.2%
1/80
0.00%
0/95
1.3%
1/75
Skin and subcutaneous tissue disorders
Xeroderma
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Skin and subcutaneous tissue disorders
Pruritus generalised
0.00%
0/212
0.00%
0/80
2.1%
2/95
0.00%
0/75
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.00%
0/212
1.2%
1/80
1.1%
1/95
1.3%
1/75
Skin and subcutaneous tissue disorders
Skin mass
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Arthralgia
3.3%
7/212
6.2%
5/80
2.1%
2/95
1.3%
1/75
Musculoskeletal and connective tissue disorders
Arthritis
0.94%
2/212
0.00%
0/80
1.1%
1/95
1.3%
1/75
Musculoskeletal and connective tissue disorders
Back pain
6.1%
13/212
2.5%
2/80
4.2%
4/95
5.3%
4/75
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
0.00%
0/212
1.2%
1/80
0.00%
0/95
1.3%
1/75
Musculoskeletal and connective tissue disorders
Muscle spasms
2.4%
5/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.94%
2/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Myalgia
2.8%
6/212
2.5%
2/80
3.2%
3/95
2.7%
2/75
Musculoskeletal and connective tissue disorders
Myositis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Osteoarthritis
1.9%
4/212
2.5%
2/80
1.1%
1/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Pain in extremity
1.9%
4/212
1.2%
1/80
2.1%
2/95
4.0%
3/75
Musculoskeletal and connective tissue disorders
Periarthritis
1.9%
4/212
1.2%
1/80
3.2%
3/95
2.7%
2/75
Musculoskeletal and connective tissue disorders
Plantar fasciitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
2.4%
5/212
2.5%
2/80
2.1%
2/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Synovial cyst
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Synovitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Tenosynovitis
1.4%
3/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Trigger finger
0.94%
2/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/212
2.5%
2/80
0.00%
0/95
0.00%
0/75
Renal and urinary disorders
Calculus bladder
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Renal and urinary disorders
Calculus ureteric
0.94%
2/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Renal and urinary disorders
Haematuria
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Renal and urinary disorders
Hypertonic bladder
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Renal and urinary disorders
IgA nephropathy
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Renal and urinary disorders
Nephrolithiasis
0.00%
0/212
0.00%
0/80
3.2%
3/95
1.3%
1/75
Renal and urinary disorders
Pollakiuria
0.47%
1/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Renal and urinary disorders
Diabetic nephropathy
0.00%
0/212
0.00%
0/80
2.1%
2/95
0.00%
0/75
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Reproductive system and breast disorders
Dysmenorrhoea
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Reproductive system and breast disorders
Prostatitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Reproductive system and breast disorders
Pruritus genital
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
General disorders
Chills
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
General disorders
Feeling abnormal
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
General disorders
Local swelling
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
General disorders
Malaise
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
General disorders
Oedema peripheral
1.4%
3/212
0.00%
0/80
1.1%
1/95
1.3%
1/75
General disorders
Pyrexia
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
General disorders
Thirst
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Investigations
Alanine aminotransferase increased
1.4%
3/212
0.00%
0/80
2.1%
2/95
4.0%
3/75
Investigations
Amylase increased
0.94%
2/212
2.5%
2/80
3.2%
3/95
1.3%
1/75
Investigations
Aspartate aminotransferase increased
0.94%
2/212
1.2%
1/80
2.1%
2/95
2.7%
2/75
Investigations
Blood bilirubin increased
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Investigations
Blood cholesterol increased
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Investigations
Blood creatine phosphokinase increased
5.7%
12/212
5.0%
4/80
6.3%
6/95
2.7%
2/75
Investigations
Blood lactate dehydrogenase increased
0.00%
0/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Investigations
Blood potassium increased
0.94%
2/212
2.5%
2/80
0.00%
0/95
1.3%
1/75
Investigations
Blood pressure increased
0.94%
2/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Investigations
Blood triglycerides increased
0.94%
2/212
1.2%
1/80
2.1%
2/95
1.3%
1/75
Investigations
Blood urea increased
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Investigations
Blood uric acid increased
1.4%
3/212
0.00%
0/80
2.1%
2/95
1.3%
1/75
Investigations
Gamma-glutamyltransferase increased
0.94%
2/212
1.2%
1/80
2.1%
2/95
1.3%
1/75
Investigations
Glucose urine present
4.7%
10/212
3.8%
3/80
7.4%
7/95
0.00%
0/75
Investigations
Blood urine present
7.1%
15/212
7.5%
6/80
9.5%
9/95
6.7%
5/75
Investigations
Haemoglobin decreased
0.00%
0/212
0.00%
0/80
1.1%
1/95
1.3%
1/75
Investigations
Lipase increased
1.4%
3/212
1.2%
1/80
4.2%
4/95
2.7%
2/75
Investigations
Low density lipoprotein increased
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Investigations
Prostatic specific antigen increased
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Investigations
Protein urine present
6.6%
14/212
7.5%
6/80
4.2%
4/95
6.7%
5/75
Investigations
Urine ketone body present
3.3%
7/212
7.5%
6/80
6.3%
6/95
2.7%
2/75
Investigations
Blood alkaline phosphatase increased
0.00%
0/212
0.00%
0/80
1.1%
1/95
2.7%
2/75
Investigations
Occult blood positive
0.00%
0/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Investigations
Helicobacter test positive
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Injury, poisoning and procedural complications
Animal bite
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Injury, poisoning and procedural complications
Arthropod sting
1.4%
3/212
3.8%
3/80
2.1%
2/95
0.00%
0/75
Injury, poisoning and procedural complications
Bite
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Injury, poisoning and procedural complications
Chillblains
1.4%
3/212
0.00%
0/80
0.00%
0/95
2.7%
2/75
Injury, poisoning and procedural complications
Epicondylitis
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Injury, poisoning and procedural complications
Hand fracture
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Injury, poisoning and procedural complications
Ligament sprain
0.47%
1/212
2.5%
2/80
2.1%
2/95
0.00%
0/75
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Injury, poisoning and procedural complications
Tendon rupture
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Injury, poisoning and procedural complications
Ulna fracture
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Injury, poisoning and procedural complications
Fractured coccyx
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Injury, poisoning and procedural complications
Excoriation
0.47%
1/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Injury, poisoning and procedural complications
Muscle strain
0.94%
2/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Injury, poisoning and procedural complications
Contusion
4.7%
10/212
6.2%
5/80
4.2%
4/95
4.0%
3/75
Injury, poisoning and procedural complications
Thermal burn
0.47%
1/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Injury, poisoning and procedural complications
Open wound
1.9%
4/212
0.00%
0/80
0.00%
0/95
5.3%
4/75
Injury, poisoning and procedural complications
Ligament injury
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Injury, poisoning and procedural complications
Skeletal injury
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Injury, poisoning and procedural complications
Tooth fracture
0.94%
2/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Injury, poisoning and procedural complications
Heat illness
0.47%
1/212
0.00%
0/80
0.00%
0/95
2.7%
2/75
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Cystitis
2.8%
6/212
1.2%
1/80
5.3%
5/95
2.7%
2/75
Infections and infestations
Dermatitis infected
0.00%
0/212
2.5%
2/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Folliculitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Gastroenteritis
1.9%
4/212
3.8%
3/80
2.1%
2/95
1.3%
1/75
Infections and infestations
Gastroenteritis viral
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Herpes simplex
0.47%
1/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Herpes zoster
1.4%
3/212
1.2%
1/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Hordeolum
1.4%
3/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Influenza
1.4%
3/212
5.0%
4/80
3.2%
3/95
2.7%
2/75
Infections and infestations
Mumps
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Nasopharyngitis
29.2%
62/212
23.8%
19/80
29.5%
28/95
28.0%
21/75
Infections and infestations
Onychomycosis
1.9%
4/212
0.00%
0/80
1.1%
1/95
0.00%
0/75
Infections and infestations
Otitis externa
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Paronychia
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Infections and infestations
Pharyngitis
5.7%
12/212
5.0%
4/80
5.3%
5/95
1.3%
1/75
Infections and infestations
Pneumonia
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Pneumonia mycoplasmal
0.00%
0/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Infections and infestations
Pulpitis dental
0.47%
1/212
1.2%
1/80
1.1%
1/95
1.3%
1/75
Infections and infestations
Pyelonephritis
0.47%
1/212
0.00%
0/80
0.00%
0/95
1.3%
1/75
Infections and infestations
Sinusitis
0.00%
0/212
0.00%
0/80
1.1%
1/95
2.7%
2/75
Infections and infestations
Acute sinusitis
0.47%
1/212
0.00%
0/80
0.00%
0/95
0.00%
0/75
Infections and infestations
Acute tonsillitis
0.47%
1/212
1.2%
1/80
1.1%
1/95
0.00%
0/75
Infections and infestations
Body tinea
0.00%
0/212
0.00%
0/80
1.1%
1/95
1.3%
1/75
Infections and infestations
Bronchitis
3.3%
7/212
8.8%
7/80
5.3%
5/95
2.7%
2/75
Infections and infestations
Cellulitis orbital
0.00%
0/212
1.2%
1/80
0.00%
0/95
0.00%
0/75

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER