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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 Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teneligliptin | Experimental | Teneligliptin for 52 weeks |
|
| Teneligliptin + Sulfonylurea | Experimental | Teneligliptin for 52 weeks in combination with sulfonylurea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneligliptin | Drug | Teneligliptin for 52 weeks |
| |
| Teneligliptin + Sulfonylurea |
| 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 Week 52 | |
| Change From Baseline in Fasting Plasma Glucose at Week 52 | Baseline and Week 52 |
Not provided
Inclusion Criteria:
In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea for diabetes over 12 weeks before administration of investigational drug
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
HbA1c criteria:
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
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 |
|---|---|---|---|---|---|---|
| Reserch site | Shikoku | 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 for 52 weeks |
| FG001 | Teneligliptin + Sulfonylurea | Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teneligliptin | Teneligliptin for 52 weeks |
| BG001 | Teneligliptin + Sulfonylurea | Teneligliptin for 52 weeks in combination with sulfonylurea |
| 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 |
|
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 for 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA 13.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute tonsillitis | Infections and infestations | MedDRA 13.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Drug |
Teneligliptin for 52 weeks in combination with sulfonylurea |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other Reason |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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 Week 52 |
|
|
|
| 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 Week 52 |
|
|
|
| 6 |
| 151 |
| 136 |
| 151 |
| EG001 | Teneligliptin + Sulfonylurea | Teneligliptin for 52 weeks in combination with sulfonylurea | 7 | 89 | 84 | 89 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Testicular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Myelopathy | Nervous system disorders | MedDRA 13.1 |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 |
|
| Chronic sinusitis | Infections and infestations | MedDRA 13.1 |
|
| Cystitis | Infections and infestations | MedDRA 13.1 |
|
| Dermatitis infected | Infections and infestations | MedDRA 13.1 |
|
| Folliculitis | Infections and infestations | MedDRA 13.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 |
|
| Herpes zoster | Infections and infestations | MedDRA 13.1 |
|
| Hordeolum | Infections and infestations | MedDRA 13.1 |
|
| Influenza | Infections and infestations | MedDRA 13.1 |
|
| Laryngitis | Infections and infestations | MedDRA 13.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 |
|
| Onychomycosis | Infections and infestations | MedDRA 13.1 |
|
| Otitis media | Infections and infestations | MedDRA 13.1 |
|
| Otitis media chronic | Infections and infestations | MedDRA 13.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 13.1 |
|
| Pulpitis dental | Infections and infestations | MedDRA 13.1 |
|
| Rhinitis | Infections and infestations | MedDRA 13.1 |
|
| Tinea pedis | Infections and infestations | MedDRA 13.1 |
|
| Tonsillitis | Infections and infestations | MedDRA 13.1 |
|
| Vulvitis | Infections and infestations | MedDRA 13.1 |
|
| Vulvovaginitis | Infections and infestations | MedDRA 13.1 |
|
| Wound infection | Infections and infestations | MedDRA 13.1 |
|
| Gastritis viral | Infections and infestations | MedDRA 13.1 |
|
| Helicobacter infection | Infections and infestations | MedDRA 13.1 |
|
| Myringitis | Infections and infestations | MedDRA 13.1 |
|
| Enterocolitis viral | Infections and infestations | MedDRA 13.1 |
|
| Cystitis bacterial | Infections and infestations | MedDRA 13.1 |
|
| Oral herpes | Infections and infestations | MedDRA 13.1 |
|
| Latent syphilis | Infections and infestations | MedDRA 13.1 |
|
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Gastrointestinal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 13.1 |
|
| Seasonal allergy | Immune system disorders | MedDRA 13.1 |
|
| Thyroid mass | Endocrine disorders | MedDRA 13.1 |
|
| Gout | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 13.1 |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 |
|
| Depression | Psychiatric disorders | MedDRA 13.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 |
|
| Schizophrenia | Psychiatric disorders | MedDRA 13.1 |
|
| Somatoform disorder gastrointestinal | Psychiatric disorders | MedDRA 13.1 |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 13.1 |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 13.1 |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 13.1 |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 |
|
| Dizziness postural | Nervous system disorders | MedDRA 13.1 |
|
| Headache | Nervous system disorders | MedDRA 13.1 |
|
| Migraine | Nervous system disorders | MedDRA 13.1 |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 |
|
| Tension headache | Nervous system disorders | MedDRA 13.1 |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 13.1 |
|
| Occipital neuralgia | Nervous system disorders | MedDRA 13.1 |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 13.1 |
|
| Cataract | Eye disorders | MedDRA 13.1 |
|
| Conjunctival granuloma | Eye disorders | MedDRA 13.1 |
|
| Conjunctivitis | Eye disorders | MedDRA 13.1 |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 13.1 |
|
| Diabetic retinopathy | Eye disorders | MedDRA 13.1 |
|
| Dry eye | Eye disorders | MedDRA 13.1 |
|
| Keratitis | Eye disorders | MedDRA 13.1 |
|
| Macular oedema | Eye disorders | MedDRA 13.1 |
|
| Strabismus | Eye disorders | MedDRA 13.1 |
|
| Vision blurred | Eye disorders | MedDRA 13.1 |
|
| Vitreous detachment | Eye disorders | MedDRA 13.1 |
|
| Vitreous floaters | Eye disorders | MedDRA 13.1 |
|
| Entropion | Eye disorders | MedDRA 13.1 |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Angina pectoris | Cardiac disorders | MedDRA 13.1 |
|
| Hypertension | Vascular disorders | MedDRA 13.1 |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Laryngeal granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 13.1 |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 13.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 13.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.1 |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 13.1 |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 13.1 |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 13.1 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 13.1 |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 13.1 |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 13.1 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA 13.1 |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 |
|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.1 |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 13.1 |
|
| Hyperplastic cholecystopathy | Hepatobiliary disorders | MedDRA 13.1 |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 13.1 |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Spinal ligament ossification | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA 13.1 |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 13.1 |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 13.1 |
|
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 13.1 |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.1 |
|
| Calculus prostatic | Reproductive system and breast disorders | MedDRA 13.1 |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 13.1 |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 13.1 |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 13.1 |
|
| Chest discomfort | General disorders | MedDRA 13.1 |
|
| Chest pain | General disorders | MedDRA 13.1 |
|
| Malaise | General disorders | MedDRA 13.1 |
|
| Oedema peripheral | General disorders | MedDRA 13.1 |
|
| Pain | General disorders | MedDRA 13.1 |
|
| Pyrexia | General disorders | MedDRA 13.1 |
|
| Vaccination site dermatitis | General disorders | MedDRA 13.1 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 |
|
| Albumin urine present | Investigations | MedDRA 13.1 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.1 |
|
| Blood creatinine increased | Investigations | MedDRA 13.1 |
|
| Blood potassium increased | Investigations | MedDRA 13.1 |
|
| Blood triglycerides increased | Investigations | MedDRA 13.1 |
|
| Blood uric acid increased | Investigations | MedDRA 13.1 |
|
| Eosinophil count increased | Investigations | MedDRA 13.1 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.1 |
|
| Glucose urine present | Investigations | MedDRA 13.1 |
|
| Blood urine present | Investigations | MedDRA 13.1 |
|
| Monocyte count decreased | Investigations | MedDRA 13.1 |
|
| White blood cell count increased | Investigations | MedDRA 13.1 |
|
| Protein urine present | Investigations | MedDRA 13.1 |
|
| Urine ketone body present | Investigations | MedDRA 13.1 |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 |
|
| Occult blood positive | Investigations | MedDRA 13.1 |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
Not provided
| D004700 | Endocrine System Diseases |
| Sulfur Compounds |