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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| teneligliptin | Experimental | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) |
|
| teneligliptin and glinide | Experimental | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide |
|
| teneligliptin and biguanide | Experimental | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide |
|
| teneligliptin and alpha-glucosidase inhibitor | Experimental | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teneligliptin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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. | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 52 | Baseline and 52 weeks | |
| Change From Baseline in Fasting Plasma Glucose at Week 52 | Baseline and 52 weeks | |
| Change From Baseline in Fasting Glucagon at Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takashi Kadowaki, Professor | Tokyo University | Study Director |
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chitose-shi | Hokkaido | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25861982 | Result | Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Teneligliptin | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) |
| FG001 | Teneligliptin and Glinide | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide |
| FG002 | Teneligliptin and Biguanide | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide |
| FG003 | Teneligliptin and Alpha-glucosidase Inhibitor | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teneligliptin | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) |
| BG001 | Teneligliptin and Glinide | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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. | 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. | Posted | Number | participants | 52 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teneligliptin | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis hypertrophic | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA(15.0) |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
| D001645 | Biguanides |
| D065089 | Glycoside Hydrolase Inhibitors |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004791 | Enzyme Inhibitors |
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| glinide | Drug |
|
| biguanide | Drug |
|
| alpha-glucosidase inhibitor | Drug |
|
| Baseline and 52 weeks |
| Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 | Baseline and 52 weeks |
| Lack of Efficacy |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Personal matter |
|
| BG002 | Teneligliptin and Biguanide | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide |
| BG003 | Teneligliptin and Alpha-glucosidase Inhibitor | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
| OG002 | Teneligliptin and Biguanide | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide |
| OG003 | Teneligliptin and Alpha-glucosidase Inhibitor | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor |
|
|
| Secondary | Change From Baseline in HbA1c at Week 52 | 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. | Posted | Mean | Standard Deviation | Percent | Baseline and 52 weeks |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 52 | 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. | Posted | Mean | Standard Deviation | mg / dL | Baseline and 52 weeks |
|
|
|
| Secondary | Change From Baseline in Fasting Glucagon at Week 52 | 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. | Posted | Mean | Standard Deviation | pg / mL | Baseline and 52 weeks |
|
|
|
| Secondary | Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 | 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. | Posted | Mean | Standard Deviation | μU / mL | Baseline and 52 weeks |
|
|
|
| 14 |
| 212 |
| 182 |
| 212 |
| EG001 | Teneligliptin and Glinide | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide | 3 | 80 | 72 | 80 |
| EG002 | Teneligliptin and Biguanide | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide | 6 | 95 | 81 | 95 |
| EG003 | Teneligliptin and Alpha-glucosidase Inhibitor | teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor | 6 | 75 | 59 | 75 |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA(15.0) |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA(15.0) |
|
| Ileus | Gastrointestinal disorders | MedDRA(15.0) |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA(15.0) |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA(15.0) |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA(15.0) |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA(15.0) |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA(15.0) |
|
| Ota's naevus | Congenital, familial and genetic disorders | MedDRA(15.0) |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Cellulitis | Infections and infestations | MedDRA(15.0) |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Thyroiditis | Endocrine disorders | MedDRA(15.0) |
|
| Cataract | Eye disorders | MedDRA(15.0) |
|
| Retinal detachment | Eye disorders | MedDRA(15.0) |
|
| Vertigo | Ear and labyrinth disorders | MedDRA(15.0) |
|
| Angina unstable | Cardiac disorders | MedDRA(15.0) |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA(15.0) |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Acute tonsillitis | Infections and infestations | MedDRA(15.0) |
|
| Body tinea | Infections and infestations | MedDRA(15.0) |
|
| Bronchitis | Infections and infestations | MedDRA(15.0) |
|
| Cellulitis orbital | Infections and infestations | MedDRA(15.0) |
|
| Cystitis | Infections and infestations | MedDRA(15.0) |
|
| Dermatitis infected | Infections and infestations | MedDRA(15.0) |
|
| Folliculitis | Infections and infestations | MedDRA(15.0) |
|
| Gastroenteritis | Infections and infestations | MedDRA(15.0) |
|
| Gastroenteritis viral | Infections and infestations | MedDRA(15.0) |
|
| Herpes simplex | Infections and infestations | MedDRA(15.0) |
|
| Herpes zoster | Infections and infestations | MedDRA(15.0) |
|
| Hordeolum | Infections and infestations | MedDRA(15.0) |
|
| Influenza | Infections and infestations | MedDRA(15.0) |
|
| Mumps | Infections and infestations | MedDRA(15.0) |
|
| Nasopharyngitis | Infections and infestations | MedDRA(15.0) |
|
| Onychomycosis | Infections and infestations | MedDRA(15.0) |
|
| Otitis externa | Infections and infestations | MedDRA(15.0) |
|
| Paronychia | Infections and infestations | MedDRA(15.0) |
|
| Pharyngitis | Infections and infestations | MedDRA(15.0) |
|
| Pneumonia | Infections and infestations | MedDRA(15.0) |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA(15.0) |
|
| Pulpitis dental | Infections and infestations | MedDRA(15.0) |
|
| Pyelonephritis | Infections and infestations | MedDRA(15.0) |
|
| Sinusitis | Infections and infestations | MedDRA(15.0) |
|
| Subcutaneous abscess | Infections and infestations | MedDRA(15.0) |
|
| Tinea pedis | Infections and infestations | MedDRA(15.0) |
|
| Tonsillitis | Infections and infestations | MedDRA(15.0) |
|
| Urethritis | Infections and infestations | MedDRA(15.0) |
|
| Urinary tract infection | Infections and infestations | MedDRA(15.0) |
|
| Vulvitis | Infections and infestations | MedDRA(15.0) |
|
| Peritonsillitis | Infections and infestations | MedDRA(15.0) |
|
| Gingival abscess | Infections and infestations | MedDRA(15.0) |
|
| Helicobacter infection | Infections and infestations | MedDRA(15.0) |
|
| Enteritis infectious | Infections and infestations | MedDRA(15.0) |
|
| Mycoplasma infection | Infections and infestations | MedDRA(15.0) |
|
| Dental gangrene | Infections and infestations | MedDRA(15.0) |
|
| Acarodermatitis | Infections and infestations | MedDRA(15.0) |
|
| Oral herpes | Infections and infestations | MedDRA(15.0) |
|
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(15.0) |
|
| Seasonal allergy | Immune system disorders | MedDRA(15.0) |
|
| Hyperthyroidism | Endocrine disorders | MedDRA(15.0) |
|
| Thyroid mass | Endocrine disorders | MedDRA(15.0) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA(15.0) |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA(15.0) |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA(15.0) |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA(15.0) |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA(15.0) |
|
| Depression | Psychiatric disorders | MedDRA(15.0) |
|
| Dysphoria | Psychiatric disorders | MedDRA(15.0) |
|
| Insomnia | Psychiatric disorders | MedDRA(15.0) |
|
| Sleep disorder | Psychiatric disorders | MedDRA(15.0) |
|
| Anxiety disorder | Psychiatric disorders | MedDRA(15.0) |
|
| Altered state of consciousness | Nervous system disorders | MedDRA(15.0) |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA(15.0) |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA(15.0) |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA(15.0) |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA(15.0) |
|
| Dizziness | Nervous system disorders | MedDRA(15.0) |
|
| Headache | Nervous system disorders | MedDRA(15.0) |
|
| Hypoaesthesia | Nervous system disorders | MedDRA(15.0) |
|
| Myelopathy | Nervous system disorders | MedDRA(15.0) |
|
| Neuralgia | Nervous system disorders | MedDRA(15.0) |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA(15.0) |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA(15.0) |
|
| Sciatica | Nervous system disorders | MedDRA(15.0) |
|
| Tremor | Nervous system disorders | MedDRA(15.0) |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA(15.0) |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA(15.0) |
|
| Asthenopia | Eye disorders | MedDRA(15.0) |
|
| Astigmatism | Eye disorders | MedDRA(15.0) |
|
| Blepharitis | Eye disorders | MedDRA(15.0) |
|
| Cataract | Eye disorders | MedDRA(15.0) |
|
| Chalazion | Eye disorders | MedDRA(15.0) |
|
| Conjunctival cyst | Eye disorders | MedDRA(15.0) |
|
| Conjunctival deposit | Eye disorders | MedDRA(15.0) |
|
| Conjunctivitis | Eye disorders | MedDRA(15.0) |
|
| Conjunctivitis allergic | Eye disorders | MedDRA(15.0) |
|
| Diabetic retinopathy | Eye disorders | MedDRA(15.0) |
|
| Dry eye | Eye disorders | MedDRA(15.0) |
|
| Eye pain | Eye disorders | MedDRA(15.0) |
|
| Iritis | Eye disorders | MedDRA(15.0) |
|
| Keratitis | Eye disorders | MedDRA(15.0) |
|
| Open angle glaucoma | Eye disorders | MedDRA(15.0) |
|
| Punctate keratitis | Eye disorders | MedDRA(15.0) |
|
| Retinal detachment | Eye disorders | MedDRA(15.0) |
|
| Retinal tear | Eye disorders | MedDRA(15.0) |
|
| Pingueculitis | Eye disorders | MedDRA(15.0) |
|
| Conjunctivochalasis | Eye disorders | MedDRA(15.0) |
|
| Ulcerative keratitis | Eye disorders | MedDRA(15.0) |
|
| Normal tension glaucoma | Eye disorders | MedDRA(15.0) |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA(15.0) |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA(15.0) |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA(15.0) |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA(15.0) |
|
| Vertigo | Ear and labyrinth disorders | MedDRA(15.0) |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA(15.0) |
|
| Deafness bilateral | Ear and labyrinth disorders | MedDRA(15.0) |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA(15.0) |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA(15.0) |
|
| Tachycardia | Cardiac disorders | MedDRA(15.0) |
|
| Hypertension | Vascular disorders | MedDRA(15.0) |
|
| Orthostatic hypotension | Vascular disorders | MedDRA(15.0) |
|
| Peripheral coldness | Vascular disorders | MedDRA(15.0) |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Allergic pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Vocal cord disorder | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA(15.0) |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA(15.0) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA(15.0) |
|
| Cheilitis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Colitis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA(15.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA(15.0) |
|
| Dental caries | Gastrointestinal disorders | MedDRA(15.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA(15.0) |
|
| Duodenal polyp | Gastrointestinal disorders | MedDRA(15.0) |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA(15.0) |
|
| Duodenitis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA(15.0) |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Flatulence | Gastrointestinal disorders | MedDRA(15.0) |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA(15.0) |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA(15.0) |
|
| Gastritis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA(15.0) |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA(15.0) |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA(15.0) |
|
| Gingivitis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Haematemesis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA(15.0) |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA(15.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA(15.0) |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA(15.0) |
|
| Periodontitis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA(15.0) |
|
| Stomatitis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Tooth loss | Gastrointestinal disorders | MedDRA(15.0) |
|
| Vomiting | Gastrointestinal disorders | MedDRA(15.0) |
|
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA(15.0) |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA(15.0) |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA(15.0) |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA(15.0) |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA(15.0) |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Dandruff | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA(15.0) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Nodal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA(15.0) |
|
| Calculus bladder | Renal and urinary disorders | MedDRA(15.0) |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA(15.0) |
|
| Haematuria | Renal and urinary disorders | MedDRA(15.0) |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA(15.0) |
|
| IgA nephropathy | Renal and urinary disorders | MedDRA(15.0) |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA(15.0) |
|
| Pollakiuria | Renal and urinary disorders | MedDRA(15.0) |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA(15.0) |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA(15.0) |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA(15.0) |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA(15.0) |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA(15.0) |
|
| Chills | General disorders | MedDRA(15.0) |
|
| Feeling abnormal | General disorders | MedDRA(15.0) |
|
| Local swelling | General disorders | MedDRA(15.0) |
|
| Malaise | General disorders | MedDRA(15.0) |
|
| Oedema peripheral | General disorders | MedDRA(15.0) |
|
| Pyrexia | General disorders | MedDRA(15.0) |
|
| Thirst | General disorders | MedDRA(15.0) |
|
| Alanine aminotransferase increased | Investigations | MedDRA(15.0) |
|
| Amylase increased | Investigations | MedDRA(15.0) |
|
| Aspartate aminotransferase increased | Investigations | MedDRA(15.0) |
|
| Blood bilirubin increased | Investigations | MedDRA(15.0) |
|
| Blood cholesterol increased | Investigations | MedDRA(15.0) |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA(15.0) |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA(15.0) |
|
| Blood potassium increased | Investigations | MedDRA(15.0) |
|
| Blood pressure increased | Investigations | MedDRA(15.0) |
|
| Blood triglycerides increased | Investigations | MedDRA(15.0) |
|
| Blood urea increased | Investigations | MedDRA(15.0) |
|
| Blood uric acid increased | Investigations | MedDRA(15.0) |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA(15.0) |
|
| Glucose urine present | Investigations | MedDRA(15.0) |
|
| Blood urine present | Investigations | MedDRA(15.0) |
|
| Haemoglobin decreased | Investigations | MedDRA(15.0) |
|
| Lipase increased | Investigations | MedDRA(15.0) |
|
| Low density lipoprotein increased | Investigations | MedDRA(15.0) |
|
| Prostatic specific antigen increased | Investigations | MedDRA(15.0) |
|
| Protein urine present | Investigations | MedDRA(15.0) |
|
| Urine ketone body present | Investigations | MedDRA(15.0) |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA(15.0) |
|
| Occult blood positive | Investigations | MedDRA(15.0) |
|
| Helicobacter test positive | Investigations | MedDRA(15.0) |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Bite | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA(15.0) |
|
Not provided
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D045504 |
| Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |