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The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo / Teneli + SU | Placebo Comparator |
| |
| Teneli / Teneli + SU | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea) | Drug | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 12 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. | at Week 0 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 12 | The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. | at Week 0 and Week 12 |
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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 |
|---|---|---|---|---|---|---|
| Sapporo | Hokkaido | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24205974 | Background | Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo / Teneli + SU | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride |
| FG001 | Teneli / Teneli + SU | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Double Blind Period |
|
| |||||||||||||||||||||
| Period 2: Open-label Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo / Teneli + SU | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride |
| BG001 | Teneli / Teneli + SU |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in HbA1c at Week 12 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. | 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 randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | at Week 0 and Week 12 |
|
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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 | Placebo/Teneli + SU (Data Through Week 12) | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown. MedDRA 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body tinea | Infections and infestations | MedDRA 13.0 |
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| 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 |
| D013453 | Sulfonylurea Compounds |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
| Teneli / Teneli + SU | Drug | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea |
|
|
| Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 |
The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. |
| 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12 |
| Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 | The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. | at Week 0 and Week 12 |
| NOT COMPLETED |
|
|
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Teneli / Teneli + SU | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride |
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 12 | The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. | 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 randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing. | Posted | Least Squares Mean | Standard Error | mg / dL | at Week 0 and Week 12 |
|
|
|
| Secondary | Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 | The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. | 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 randomization. | Posted | Least Squares Mean | Standard Error | mg・hr/dL | 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12 |
|
|
|
| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 | The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. | 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 randomization. | Posted | Least Squares Mean | Standard Error | mg / dL | at Week 0 and Week 12 |
|
|
|
| 2 |
| 98 |
| 60 |
| 98 |
| EG001 | Teneli/Teneli + SU (Data Through Week 12) | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown. MedDRA 13.0 | 0 | 96 | 62 | 96 |
| EG002 | Placebo/Teneli + SU (Data From Week 12 to Week 52) | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown. MedDRA 13.1 | 2 | 95 | 89 | 95 |
| EG003 | Teneli/Teneli + SU (Data Through Week 52) | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown. MedDRA 13.1 | 7 | 96 | 89 | 96 |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 13.0 and 13.1 |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 and 13.1 |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 and 13.1 |
|
| Maculopathy | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Cataract | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Retinal vein occlusion | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 13.0 and 13.1 |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 13.0 and 13.1 |
|
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Ovarian enlargement | Reproductive system and breast disorders | MedDRA 13.0 and 13.1 |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Bronchopneumonia | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Cellulitis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Cystitis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Dermatitis infected | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Folliculitis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Gastroenteritis vibrio | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Herpes zoster | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Impetigo | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Infected bites | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Influenza | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Onychomycosis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Otitis externa | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Tinea cruris | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Tinea pedis | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Wound infection | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Anal abscess | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Infected epidermal cyst | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Gingival abscess | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Helicobacter infection | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Enteritis infectious | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Oral herpes | Infections and infestations | MedDRA 13.0 and 13.1 |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 and 13.1 |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 and 13.1 |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 13.0 and 13.1 |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 13.0 and 13.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 and 13.1 |
|
| Depression | Psychiatric disorders | MedDRA 13.0 and 13.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 and 13.1 |
|
| Sleep disorder | Psychiatric disorders | MedDRA 13.0 and 13.1 |
|
| Cerebral infarction | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Headache | Nervous system disorders | MedDRA 13.0 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Migraine | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Parkinson's disease | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Occipital neuralgia | Nervous system disorders | MedDRA 13.0 and 13.1 |
|
| Cataract | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Conjunctivitis | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Diabetic retinopathy | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Eyelid ptosis | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Keratitis | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Trichiasis | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Vision blurred | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Visual acuity reduced | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Vitreous floaters | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Normal tension glaucoma | Eye disorders | MedDRA 13.0 and 13.1 |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 and 13.1 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 and 13.1 |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 13.0 and 13.1 |
|
| External ear pain | Ear and labyrinth disorders | MedDRA 13.0 and 13.1 |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 and 13.1 |
|
| Palpitations | Cardiac disorders | MedDRA 13.0 and 13.1 |
|
| Hypertension | Vascular disorders | MedDRA 13.0 and 13.1 |
|
| Hot flush | Vascular disorders | MedDRA 13.0 and 13.1 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 and 13.1 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Periproctitis | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.0 and 13.1 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.0 and 13.1 |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 13.0 and 13.1 |
|
| Jaundice | Hepatobiliary disorders | MedDRA 13.0 and 13.1 |
|
| Cutaneous amyloidosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Senile pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Hyperkeratosis palmaris and plantaris | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 13.0 and 13.1 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 and 13.1 |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 13.0 and 13.1 |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA 13.0 and 13.1 |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.0 and 13.1 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 and 13.1 |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.0 and 13.1 |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.0 and 13.1 |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 13.0 and 13.1 |
|
| Chest pain | General disorders | MedDRA 13.0 and 13.1 |
|
| Feeling abnormal | General disorders | MedDRA 13.0 and 13.1 |
|
| Malaise | General disorders | MedDRA 13.0 and 13.1 |
|
| Oedema peripheral | General disorders | MedDRA 13.0 and 13.1 |
|
| Thirst | General disorders | MedDRA 13.0 and 13.1 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 and 13.1 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 and 13.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.0 and 13.1 |
|
| Blood potassium increased | Investigations | MedDRA 13.0 |
|
| Blood pressure decreased | Investigations | MedDRA 13.0 and 13.1 |
|
| Blood triglycerides increased | Investigations | MedDRA 13.0 and 13.1 |
|
| Blood urea increased | Investigations | MedDRA 13.0 and 13.1 |
|
| Blood uric acid increased | Investigations | MedDRA 13.0 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 |
|
| Glucose urine present | Investigations | MedDRA 13.0 and 13.1 |
|
| Blood urine present | Investigations | MedDRA 13.0 and 13.1 |
|
| Platelet count decreased | Investigations | MedDRA 13.0 and 13.1 |
|
| White blood cell count decreased | Investigations | MedDRA 13.0 and 13.1 |
|
| White blood cell count increased | Investigations | MedDRA 13.0 and 13.1 |
|
| Protein urine present | Investigations | MedDRA 13.0 and 13.1 |
|
| Urine ketone body present | Investigations | MedDRA 13.0 and 13.1 |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 and 13.1 |
|
| Carotid intima-media thickness increased | Investigations | MedDRA 13.0 and 13.1 |
|
| Helicobacter test positive | Investigations | MedDRA 13.0 and 13.1 |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Bite | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Eye penetration | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Nail avulsion | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Stab wound | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Ear abrasion | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA 13.0 |
|
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 13.0 and 13.1 |
|
Not provided
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| Sulfur Compounds |