Adverse Events Module

Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module


Ignite Creation Date: 2025-12-25 @ 2:55 AM
Ignite Modification Date: 2025-12-26 @ 1:35 AM
NCT ID: NCT01301833
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01301833
Study Brief: Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Teneligliptin and Glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide None None 3 80 72 80 View
Teneligliptin teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) None None 14 212 182 212 View
Teneligliptin and Biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide None None 6 95 81 95 View
Teneligliptin and Alpha-glucosidase Inhibitor teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor None None 6 75 59 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rhinitis hypertrophic None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Sleep apnoea syndrome None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Colonic polyp None Gastrointestinal disorders MedDRA(15.0) View
Enterocolitis None Gastrointestinal disorders MedDRA(15.0) View
Haemorrhoids None Gastrointestinal disorders MedDRA(15.0) View
Ileus None Gastrointestinal disorders MedDRA(15.0) View
Inguinal hernia None Gastrointestinal disorders MedDRA(15.0) View
Mallory-Weiss syndrome None Gastrointestinal disorders MedDRA(15.0) View
Bile duct stone None Hepatobiliary disorders MedDRA(15.0) View
Calculus ureteric None Renal and urinary disorders MedDRA(15.0) View
Nephrolithiasis None Renal and urinary disorders MedDRA(15.0) View
Ota's naevus None Congenital, familial and genetic disorders MedDRA(15.0) View
Upper limb fracture None Injury, poisoning and procedural complications MedDRA(15.0) View
Cellulitis None Infections and infestations MedDRA(15.0) View
Gastric cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Large intestine carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Thyroid cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Uterine cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Thyroiditis None Endocrine disorders MedDRA(15.0) View
Cataract None Eye disorders MedDRA(15.0) View
Retinal detachment None Eye disorders MedDRA(15.0) View
Vertigo None Ear and labyrinth disorders MedDRA(15.0) View
Angina unstable None Cardiac disorders MedDRA(15.0) View
Supraventricular tachycardia None Cardiac disorders MedDRA(15.0) View
Organising pneumonia None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Onychomycosis None Infections and infestations MedDRA(15.0) View
Otitis externa None Infections and infestations MedDRA(15.0) View
Paronychia None Infections and infestations MedDRA(15.0) View
Pharyngitis None Infections and infestations MedDRA(15.0) View
Pneumonia None Infections and infestations MedDRA(15.0) View
Pneumonia mycoplasmal None Infections and infestations MedDRA(15.0) View
Pulpitis dental None Infections and infestations MedDRA(15.0) View
Pyelonephritis None Infections and infestations MedDRA(15.0) View
Sinusitis None Infections and infestations MedDRA(15.0) View
Subcutaneous abscess None Infections and infestations MedDRA(15.0) View
Urethritis None Infections and infestations MedDRA(15.0) View
Urinary tract infection None Infections and infestations MedDRA(15.0) View
Vulvitis None Infections and infestations MedDRA(15.0) View
Peritonsillitis None Infections and infestations MedDRA(15.0) View
Gingival abscess None Infections and infestations MedDRA(15.0) View
Helicobacter infection None Infections and infestations MedDRA(15.0) View
Enteritis infectious None Infections and infestations MedDRA(15.0) View
Mycoplasma infection None Infections and infestations MedDRA(15.0) View
Dental gangrene None Infections and infestations MedDRA(15.0) View
Acarodermatitis None Infections and infestations MedDRA(15.0) View
Oral herpes None Infections and infestations MedDRA(15.0) View
Haemangioma of liver None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Lipoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Seborrhoeic keratosis None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Thyroid neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Uterine leiomyoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA(15.0) View
Seasonal allergy None Immune system disorders MedDRA(15.0) View
Hyperthyroidism None Endocrine disorders MedDRA(15.0) View
Thyroid mass None Endocrine disorders MedDRA(15.0) View
Dehydration None Metabolism and nutrition disorders MedDRA(15.0) View
Hypoglycaemia None Metabolism and nutrition disorders MedDRA(15.0) View
Decreased appetite None Metabolism and nutrition disorders MedDRA(15.0) View
Hyperlipidaemia None Metabolism and nutrition disorders MedDRA(15.0) View
Depression None Psychiatric disorders MedDRA(15.0) View
Dysphoria None Psychiatric disorders MedDRA(15.0) View
Insomnia None Psychiatric disorders MedDRA(15.0) View
Sleep disorder None Psychiatric disorders MedDRA(15.0) View
Anxiety disorder None Psychiatric disorders MedDRA(15.0) View
Altered state of consciousness None Nervous system disorders MedDRA(15.0) View
Carotid artery stenosis None Nervous system disorders MedDRA(15.0) View
Carpal tunnel syndrome None Nervous system disorders MedDRA(15.0) View
Cervicobrachial syndrome None Nervous system disorders MedDRA(15.0) View
Diabetic neuropathy None Nervous system disorders MedDRA(15.0) View
Dizziness None Nervous system disorders MedDRA(15.0) View
Headache None Nervous system disorders MedDRA(15.0) View
Hypoaesthesia None Nervous system disorders MedDRA(15.0) View
Myelopathy None Nervous system disorders MedDRA(15.0) View
Neuralgia None Nervous system disorders MedDRA(15.0) View
Neuropathy peripheral None Nervous system disorders MedDRA(15.0) View
Post herpetic neuralgia None Nervous system disorders MedDRA(15.0) View
Sciatica None Nervous system disorders MedDRA(15.0) View
Tremor None Nervous system disorders MedDRA(15.0) View
Intercostal neuralgia None Nervous system disorders MedDRA(15.0) View
Carotid arteriosclerosis None Nervous system disorders MedDRA(15.0) View
Asthenopia None Eye disorders MedDRA(15.0) View
Astigmatism None Eye disorders MedDRA(15.0) View
Blepharitis None Eye disorders MedDRA(15.0) View
Cataract None Eye disorders MedDRA(15.0) View
Chalazion None Eye disorders MedDRA(15.0) View
Conjunctival cyst None Eye disorders MedDRA(15.0) View
Conjunctival deposit None Eye disorders MedDRA(15.0) View
Conjunctivitis None Eye disorders MedDRA(15.0) View
Conjunctivitis allergic None Eye disorders MedDRA(15.0) View
Diabetic retinopathy None Eye disorders MedDRA(15.0) View
Dry eye None Eye disorders MedDRA(15.0) View
Eye pain None Eye disorders MedDRA(15.0) View
Iritis None Eye disorders MedDRA(15.0) View
Keratitis None Eye disorders MedDRA(15.0) View
Open angle glaucoma None Eye disorders MedDRA(15.0) View
Punctate keratitis None Eye disorders MedDRA(15.0) View
Retinal detachment None Eye disorders MedDRA(15.0) View
Retinal tear None Eye disorders MedDRA(15.0) View
Pingueculitis None Eye disorders MedDRA(15.0) View
Ulcerative keratitis None Eye disorders MedDRA(15.0) View
Normal tension glaucoma None Eye disorders MedDRA(15.0) View
Deafness neurosensory None Ear and labyrinth disorders MedDRA(15.0) View
Meniere's disease None Ear and labyrinth disorders MedDRA(15.0) View
Motion sickness None Ear and labyrinth disorders MedDRA(15.0) View
Tinnitus None Ear and labyrinth disorders MedDRA(15.0) View
Vertigo None Ear and labyrinth disorders MedDRA(15.0) View
Vertigo positional None Ear and labyrinth disorders MedDRA(15.0) View
Deafness bilateral None Ear and labyrinth disorders MedDRA(15.0) View
Hypertension None Vascular disorders MedDRA(15.0) View
Orthostatic hypotension None Vascular disorders MedDRA(15.0) View
Peripheral coldness None Vascular disorders MedDRA(15.0) View
Asthma None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Cough None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Rhinitis allergic None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Sleep apnoea syndrome None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Allergic pharyngitis None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Vocal cord disorder None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Oropharyngeal discomfort None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Abdominal discomfort None Gastrointestinal disorders MedDRA(15.0) View
Abdominal distension None Gastrointestinal disorders MedDRA(15.0) View
Abdominal pain upper None Gastrointestinal disorders MedDRA(15.0) View
Cheilitis None Gastrointestinal disorders MedDRA(15.0) View
Colitis None Gastrointestinal disorders MedDRA(15.0) View
Diarrhoea None Gastrointestinal disorders MedDRA(15.0) View
Duodenal polyp None Gastrointestinal disorders MedDRA(15.0) View
Duodenal ulcer None Gastrointestinal disorders MedDRA(15.0) View
Duodenitis None Gastrointestinal disorders MedDRA(15.0) View
Dyspepsia None Gastrointestinal disorders MedDRA(15.0) View
Enterocolitis None Gastrointestinal disorders MedDRA(15.0) View
Flatulence None Gastrointestinal disorders MedDRA(15.0) View
Gastric polyps None Gastrointestinal disorders MedDRA(15.0) View
Gastric ulcer None Gastrointestinal disorders MedDRA(15.0) View
Gastritis None Gastrointestinal disorders MedDRA(15.0) View
Gastritis atrophic None Gastrointestinal disorders MedDRA(15.0) View
Gastritis erosive None Gastrointestinal disorders MedDRA(15.0) View
Gastrooesophageal reflux disease None Gastrointestinal disorders MedDRA(15.0) View
Gingivitis None Gastrointestinal disorders MedDRA(15.0) View
Haematemesis None Gastrointestinal disorders MedDRA(15.0) View
Haemorrhoids None Gastrointestinal disorders MedDRA(15.0) View
Hiatus hernia None Gastrointestinal disorders MedDRA(15.0) View
Rectal polyp None Gastrointestinal disorders MedDRA(15.0) View
Stomatitis None Gastrointestinal disorders MedDRA(15.0) View
Tooth loss None Gastrointestinal disorders MedDRA(15.0) View
Vomiting None Gastrointestinal disorders MedDRA(15.0) View
Haemorrhagic erosive gastritis None Gastrointestinal disorders MedDRA(15.0) View
Cholecystitis None Hepatobiliary disorders MedDRA(15.0) View
Cholelithiasis None Hepatobiliary disorders MedDRA(15.0) View
Hepatic steatosis None Hepatobiliary disorders MedDRA(15.0) View
Gallbladder polyp None Hepatobiliary disorders MedDRA(15.0) View
Acne None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Dandruff None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Dermal cyst None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Dermatitis None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Dermatitis allergic None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Dermatitis contact None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Dry skin None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Dyshidrosis None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Hyperkeratosis None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Ingrowing nail None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Photosensitivity reaction None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Prurigo None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Pruritus None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Rash None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Skin exfoliation None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Urticaria None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Xeroderma None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Pruritus generalised None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Toxic skin eruption None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Skin mass None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Arthritis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Back pain None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Dupuytren's contracture None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Lumbar spinal stenosis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Muscle spasms None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Myalgia None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Myositis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Neck pain None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Nodal osteoarthritis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Osteoarthritis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Pain in extremity None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Periarthritis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Plantar fasciitis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Rheumatoid arthritis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Spinal osteoarthritis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Synovial cyst None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Synovitis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Tenosynovitis None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Trigger finger None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Musculoskeletal stiffness None Musculoskeletal and connective tissue disorders MedDRA(15.0) View
Calculus bladder None Renal and urinary disorders MedDRA(15.0) View
Calculus ureteric None Renal and urinary disorders MedDRA(15.0) View
Hypertonic bladder None Renal and urinary disorders MedDRA(15.0) View
IgA nephropathy None Renal and urinary disorders MedDRA(15.0) View
Nephrolithiasis None Renal and urinary disorders MedDRA(15.0) View
Pollakiuria None Renal and urinary disorders MedDRA(15.0) View
Diabetic nephropathy None Renal and urinary disorders MedDRA(15.0) View
Benign prostatic hyperplasia None Reproductive system and breast disorders MedDRA(15.0) View
Dysmenorrhoea None Reproductive system and breast disorders MedDRA(15.0) View
Prostatitis None Reproductive system and breast disorders MedDRA(15.0) View
Pruritus genital None Reproductive system and breast disorders MedDRA(15.0) View
Chills None General disorders MedDRA(15.0) View
Feeling abnormal None General disorders MedDRA(15.0) View
Local swelling None General disorders MedDRA(15.0) View
Malaise None General disorders MedDRA(15.0) View
Oedema peripheral None General disorders MedDRA(15.0) View
Pyrexia None General disorders MedDRA(15.0) View
Thirst None General disorders MedDRA(15.0) View
Alanine aminotransferase increased None Investigations MedDRA(15.0) View
Amylase increased None Investigations MedDRA(15.0) View
Aspartate aminotransferase increased None Investigations MedDRA(15.0) View
Blood bilirubin increased None Investigations MedDRA(15.0) View
Blood cholesterol increased None Investigations MedDRA(15.0) View
Blood creatine phosphokinase increased None Investigations MedDRA(15.0) View
Blood lactate dehydrogenase increased None Investigations MedDRA(15.0) View
Blood potassium increased None Investigations MedDRA(15.0) View
Blood pressure increased None Investigations MedDRA(15.0) View
Blood triglycerides increased None Investigations MedDRA(15.0) View
Prostatic specific antigen increased None Investigations MedDRA(15.0) View
Protein urine present None Investigations MedDRA(15.0) View
Urine ketone body present None Investigations MedDRA(15.0) View
Blood alkaline phosphatase increased None Investigations MedDRA(15.0) View
Occult blood positive None Investigations MedDRA(15.0) View
Helicobacter test positive None Investigations MedDRA(15.0) View
Animal bite None Injury, poisoning and procedural complications MedDRA(15.0) View
Arthropod sting None Injury, poisoning and procedural complications MedDRA(15.0) View
Bite None Injury, poisoning and procedural complications MedDRA(15.0) View
Chillblains None Injury, poisoning and procedural complications MedDRA(15.0) View
Epicondylitis None Injury, poisoning and procedural complications MedDRA(15.0) View
Hand fracture None Injury, poisoning and procedural complications MedDRA(15.0) View
Ligament sprain None Injury, poisoning and procedural complications MedDRA(15.0) View
Thermal burn None Injury, poisoning and procedural complications MedDRA(15.0) View
Open wound None Injury, poisoning and procedural complications MedDRA(15.0) View
Ligament injury None Injury, poisoning and procedural complications MedDRA(15.0) View
Skeletal injury None Injury, poisoning and procedural complications MedDRA(15.0) View
Tooth fracture None Injury, poisoning and procedural complications MedDRA(15.0) View
Heat illness None Injury, poisoning and procedural complications MedDRA(15.0) View
Gastroenteritis viral None Infections and infestations MedDRA(15.0) View
Mumps None Infections and infestations MedDRA(15.0) View
Acute sinusitis None Infections and infestations MedDRA(15.0) View
Acute tonsillitis None Infections and infestations MedDRA(15.0) View
Body tinea None Infections and infestations MedDRA(15.0) View
Bronchitis None Infections and infestations MedDRA(15.0) View
Cellulitis orbital None Infections and infestations MedDRA(15.0) View
Cystitis None Infections and infestations MedDRA(15.0) View
Dermatitis infected None Infections and infestations MedDRA(15.0) View
Folliculitis None Infections and infestations MedDRA(15.0) View
Gastroenteritis None Infections and infestations MedDRA(15.0) View
Herpes simplex None Infections and infestations MedDRA(15.0) View
Herpes zoster None Infections and infestations MedDRA(15.0) View
Hordeolum None Infections and infestations MedDRA(15.0) View
Influenza None Infections and infestations MedDRA(15.0) View
Nasopharyngitis None Infections and infestations MedDRA(15.0) View
Tinea pedis None Infections and infestations MedDRA(15.0) View
Tonsillitis None Infections and infestations MedDRA(15.0) View
Hyperuricaemia None Metabolism and nutrition disorders MedDRA(15.0) View
Conjunctivochalasis None Eye disorders MedDRA(15.0) View
Aortic valve stenosis None Cardiac disorders MedDRA(15.0) View
Supraventricular tachycardia None Cardiac disorders MedDRA(15.0) View
Tachycardia None Cardiac disorders MedDRA(15.0) View
Sputum increased None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Tonsillar hypertrophy None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders MedDRA(15.0) View
Colonic polyp None Gastrointestinal disorders MedDRA(15.0) View
Constipation None Gastrointestinal disorders MedDRA(15.0) View
Dental caries None Gastrointestinal disorders MedDRA(15.0) View
Nausea None Gastrointestinal disorders MedDRA(15.0) View
Periodontal disease None Gastrointestinal disorders MedDRA(15.0) View
Periodontitis None Gastrointestinal disorders MedDRA(15.0) View
Eczema None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Eczema asteatotic None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Heat rash None Skin and subcutaneous tissue disorders MedDRA(15.0) View
Haematuria None Renal and urinary disorders MedDRA(15.0) View
Blood urea increased None Investigations MedDRA(15.0) View
Blood uric acid increased None Investigations MedDRA(15.0) View
Gamma-glutamyltransferase increased None Investigations MedDRA(15.0) View
Glucose urine present None Investigations MedDRA(15.0) View
Blood urine present None Investigations MedDRA(15.0) View
Haemoglobin decreased None Investigations MedDRA(15.0) View
Lipase increased None Investigations MedDRA(15.0) View
Low density lipoprotein increased None Investigations MedDRA(15.0) View
Rib fracture None Injury, poisoning and procedural complications MedDRA(15.0) View
Tendon rupture None Injury, poisoning and procedural complications MedDRA(15.0) View
Ulna fracture None Injury, poisoning and procedural complications MedDRA(15.0) View
Fractured coccyx None Injury, poisoning and procedural complications MedDRA(15.0) View
Excoriation None Injury, poisoning and procedural complications MedDRA(15.0) View
Muscle strain None Injury, poisoning and procedural complications MedDRA(15.0) View
Contusion None Injury, poisoning and procedural complications MedDRA(15.0) View
Post-traumatic neck syndrome None Injury, poisoning and procedural complications MedDRA(15.0) View