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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT00628212
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00628212
Study Brief:
Efficacy and 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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Teneligliptin placebo-matching tablets, orally, once daily | None | None | 1 | 80 | 44 | 80 | View |
| Teneligliptin 10 mg | Teneligliptin 10 mg, orally, once daily | None | None | 0 | 84 | 50 | 84 | View |
| Teneligliptin 20 mg | Teneligliptin 20 mg, orally, once daily | None | None | 0 | 79 | 40 | 79 | View |
| Teneligliptin 40 mg | Teneligliptin 40 mg, orally, once daily | None | None | 0 | 81 | 46 | 81 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Metastatic neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute tonsillitis | None | Infections and infestations | MedDRA (11.1) | View |
| Bronchitis | None | Infections and infestations | MedDRA (11.1) | View |
| Chronic sinusitis | None | Infections and infestations | MedDRA (11.1) | View |
| Cystitis | None | Infections and infestations | MedDRA (11.1) | View |
| Fungal skin infection | None | Infections and infestations | MedDRA (11.1) | View |
| Herpes zoster | None | Infections and infestations | MedDRA (11.1) | View |
| Hordeolum | None | Infections and infestations | MedDRA (11.1) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (11.1) | View |
| Onychomycosis | None | Infections and infestations | MedDRA (11.1) | View |
| Paronychia | None | Infections and infestations | MedDRA (11.1) | View |
| Pharyngitis | None | Infections and infestations | MedDRA (11.1) | View |
| Pneumonia | None | Infections and infestations | MedDRA (11.1) | View |
| Rhinitis | None | Infections and infestations | MedDRA (11.1) | View |
| Tinea pedis | None | Infections and infestations | MedDRA (11.1) | View |
| Tonsillitis | None | Infections and infestations | MedDRA (11.1) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (11.1) | View |
| Acarodermatitis | None | Infections and infestations | MedDRA (11.1) | View |
| Oral herpes | None | Infections and infestations | MedDRA (11.1) | View |
| Tinea manuum | None | Infections and infestations | MedDRA (11.1) | View |
| Seborrhoeic keratosis | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Lung neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Iron deficiency anaemia | None | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Lymphadenopathy | None | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Hypothyroidism | None | Endocrine disorders | MedDRA (11.1) | View |
| Gout | None | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Hyperuricaemia | None | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Hyperlipidaemia | None | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (11.1) | View |
| Carpal tunnel syndrome | None | Nervous system disorders | MedDRA (11.1) | View |
| Diabetic neuropathy | None | Nervous system disorders | MedDRA (11.1) | View |
| Dizziness | None | Nervous system disorders | MedDRA (11.1) | View |
| Headache | None | Nervous system disorders | MedDRA (11.1) | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA (11.1) | View |
| Migraine | None | Nervous system disorders | MedDRA (11.1) | View |
| Neuralgia | None | Nervous system disorders | MedDRA (11.1) | View |
| Somnolence | None | Nervous system disorders | MedDRA (11.1) | View |
| Syncope vasovagal | None | Nervous system disorders | MedDRA (11.1) | View |
| Blepharitis | None | Eye disorders | MedDRA (11.1) | View |
| Cataract | None | Eye disorders | MedDRA (11.1) | View |
| Conjunctivitis | None | Eye disorders | MedDRA (11.1) | View |
| Conjunctivitis allergic | None | Eye disorders | MedDRA (11.1) | View |
| Diabetic retinopathy | None | Eye disorders | MedDRA (11.1) | View |
| Dry eye | None | Eye disorders | MedDRA (11.1) | View |
| Glaucoma | None | Eye disorders | MedDRA (11.1) | View |
| Keratitis | None | Eye disorders | MedDRA (11.1) | View |
| Keratoconjunctivitis sicca | None | Eye disorders | MedDRA (11.1) | View |
| Macular degeneration | None | Eye disorders | MedDRA (11.1) | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA (11.1) | View |
| Hypotension | None | Vascular disorders | MedDRA (11.1) | View |
| Neurogenic shock | None | Vascular disorders | MedDRA (11.1) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Rhinitis allergic | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Cheilitis | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Colitis ischaemic | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Colonic polyp | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Duodenal ulcer | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Enterocolitis | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Flatulence | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Gastric polyps | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Gastric ulcer | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Gastritis | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Gastritis erosive | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Gingivitis | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Reflux oesophagitis | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Stomach discomfort | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Tooth loss | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Dyschezia | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Gastrointestinal motility disorder | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Hepatic steatosis | None | Hepatobiliary disorders | MedDRA (11.1) | View |
| Dermatitis | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Dermatitis contact | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Dyshidrosis | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Eczema | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Eczema asteatotic | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Hyperkeratosis | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Prurigo | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Psoriasis | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Rash pruritic | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Urticaria thermal | None | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Flank pain | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Neck pain | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Pain in jaw | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Periarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Spinal osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Tenosynovitis | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Musculoskeletal stiffness | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Intervertebral disc disorder | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Calculus ureteric | None | Renal and urinary disorders | MedDRA (11.1) | View |
| Calculus urinary | None | Renal and urinary disorders | MedDRA (11.1) | View |
| Hydronephrosis | None | Renal and urinary disorders | MedDRA (11.1) | View |
| Nephrolithiasis | None | Renal and urinary disorders | MedDRA (11.1) | View |
| Benign prostatic hyperplasia | None | Reproductive system and breast disorders | MedDRA (11.1) | View |
| Erectile dysfunction | None | Reproductive system and breast disorders | MedDRA (11.1) | View |
| Chills | None | General disorders | MedDRA (11.1) | View |
| Fatigue | None | General disorders | MedDRA (11.1) | View |
| Malaise | None | General disorders | MedDRA (11.1) | View |
| Oedema peripheral | None | General disorders | MedDRA (11.1) | View |
| Pain | None | General disorders | MedDRA (11.1) | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA (11.1) | View |
| Blood creatinine increased | None | Investigations | MedDRA (11.1) | View |
| Blood lactate dehydrogenase increased | None | Investigations | MedDRA (11.1) | View |
| Blood potassium increased | None | Investigations | MedDRA (11.1) | View |
| Blood triglycerides increased | None | Investigations | MedDRA (11.1) | View |
| Blood uric acid increased | None | Investigations | MedDRA (11.1) | View |
| Gamma-glutamyltransferase increased | None | Investigations | MedDRA (11.1) | View |
| Glucose urine present | None | Investigations | MedDRA (11.1) | View |
| Blood urine present | None | Investigations | MedDRA (11.1) | View |
| White blood cell count increased | None | Investigations | MedDRA (11.1) | View |
| Protein urine present | None | Investigations | MedDRA (11.1) | View |
| Urobilin urine present | None | Investigations | MedDRA (11.1) | View |
| Urine ketone body present | None | Investigations | MedDRA (11.1) | View |
| Blood alkaline phosphatase increased | None | Investigations | MedDRA (11.1) | View |
| Arthropod sting | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Deafness traumatic | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Foot fracture | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Joint sprain | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Traumatic haematoma | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Excoriation | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Neck injury | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA (11.1) | View |