Adverse Events Module

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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 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT01022112
Description: None
Frequency Threshold: 0
Time Frame: 14 weeks
Study: NCT01022112
Study Brief: An Efficacy, Safety, and Tolerability Study for TA-7284 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
TA-7284-Low TA-7284 50 mg, once daily for 12 weeks None None 1 82 36 82 View
TA-7284-Low-middle TA-7284 100 mg, once daily for 12 weeks None None 0 74 34 74 View
TA-7284-High-middle TA-7284 200 mg, once daily for 12 weeks None None 0 77 38 77 View
TA-7284-High TA-7284 300 mg, once daily for 12 weeks None None 0 75 34 75 View
Placebo TA-7284 Placebo, once daily for 12 weeks None None 0 75 26 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lung adenocarcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis None Infections and infestations MedDRA 13.0 View
Enteritis infectious None Infections and infestations MedDRA 13.0 View
Gastroenteritis None Infections and infestations MedDRA 13.0 View
Hordeolum None Infections and infestations MedDRA 13.0 View
Localised infection None Infections and infestations MedDRA 13.0 View
Nasopharyngitis None Infections and infestations MedDRA 13.0 View
Pharyngitis None Infections and infestations MedDRA 13.0 View
Pilonidal cyst None Infections and infestations MedDRA 13.0 View
Rhinitis None Infections and infestations MedDRA 13.0 View
Stitch abscess None Infections and infestations MedDRA 13.0 View
Upper respiratory tract infection bacterial None Infections and infestations MedDRA 13.0 View
Vulvitis None Infections and infestations MedDRA 13.0 View
Vulvovaginal candidiasis None Infections and infestations MedDRA 13.0 View
Decreased appetite None Metabolism and nutrition disorders MedDRA 13.0 View
Dehydration None Metabolism and nutrition disorders MedDRA 13.0 View
Hyperlipidaemia None Metabolism and nutrition disorders MedDRA 13.0 View
Hypoglycaemia None Metabolism and nutrition disorders MedDRA 13.0 View
Hypoglycaemia unawareness None Metabolism and nutrition disorders MedDRA 13.0 View
Depressive symptom None Psychiatric disorders MedDRA 13.0 View
Middle insomnia None Psychiatric disorders MedDRA 13.0 View
Dizziness None Nervous system disorders MedDRA 13.0 View
Facial palsy None Nervous system disorders MedDRA 13.0 View
Hypoaesthesia None Nervous system disorders MedDRA 13.0 View
Sciatica None Nervous system disorders MedDRA 13.0 View
Conjunctival haemorrhage None Eye disorders MedDRA 13.0 View
Conjunctivitis None Eye disorders MedDRA 13.0 View
Conjunctivitis allergic None Eye disorders MedDRA 13.0 View
Glaucoma None Eye disorders MedDRA 13.0 View
Vertigo None Ear and labyrinth disorders MedDRA 13.0 View
Atrial fibrillation None Cardiac disorders MedDRA 13.0 View
Palpitations None Cardiac disorders MedDRA 13.0 View
Hypertension None Vascular disorders MedDRA 13.0 View
Peripheral coldness None Vascular disorders MedDRA 13.0 View
Cough None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Epistaxis None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hiccups None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Abdominal discomfort None Gastrointestinal disorders MedDRA 13.0 View
Abdominal distension None Gastrointestinal disorders MedDRA 13.0 View
Abdominal pain None Gastrointestinal disorders MedDRA 13.0 View
Abdominal pain upper None Gastrointestinal disorders MedDRA 13.0 View
Cheilitis None Gastrointestinal disorders MedDRA 13.0 View
Constipation None Gastrointestinal disorders MedDRA 13.0 View
Dental caries None Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea None Gastrointestinal disorders MedDRA 13.0 View
Dyspepsia None Gastrointestinal disorders MedDRA 13.0 View
Gastritis None Gastrointestinal disorders MedDRA 13.0 View
Gastritis erosive None Gastrointestinal disorders MedDRA 13.0 View
Gingivitis None Gastrointestinal disorders MedDRA 13.0 View
Haemorrhoids None Gastrointestinal disorders MedDRA 13.0 View
Nausea None Gastrointestinal disorders MedDRA 13.0 View
Oral discomfort None Gastrointestinal disorders MedDRA 13.0 View
Periodontitis None Gastrointestinal disorders MedDRA 13.0 View
Tongue discolouration None Gastrointestinal disorders MedDRA 13.0 View
Vomiting None Gastrointestinal disorders MedDRA 13.0 View
Alopecia areata None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis atopic None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis contact None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Eczema None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Eczema asteatotic None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pruritus None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Urticaria None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Arthritis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Back pain None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Bone pain None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Intervertebral disc protrusion None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Joint stiffness None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscle spasms None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Musculoskeletal stiffness None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Myalgia None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Periarthritis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Spinal osteoarthritis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Hypertonic bladder None Renal and urinary disorders MedDRA 13.0 View
Pollakiuria None Renal and urinary disorders MedDRA 13.0 View
Urinary incontinence None Renal and urinary disorders MedDRA 13.0 View
Benign prostatic hyperplasia None Reproductive system and breast disorders MedDRA 13.0 View
Dysmenorrhoea None Reproductive system and breast disorders MedDRA 13.0 View
Menopausal symptoms None Reproductive system and breast disorders MedDRA 13.0 View
Pruritus genital None Reproductive system and breast disorders MedDRA 13.0 View
Vulvar erosion None Reproductive system and breast disorders MedDRA 13.0 View
Chest discomfort None General disorders MedDRA 13.0 View
Chest pain None General disorders MedDRA 13.0 View
Hunger None General disorders MedDRA 13.0 View
Malaise None General disorders MedDRA 13.0 View
Thirst None General disorders MedDRA 13.0 View
Activated partial thromboplastin time prolonged None Investigations MedDRA 13.0 View
Alanine aminotransferase increased None Investigations MedDRA 13.0 View
Blood creatine phosphokinase increased None Investigations MedDRA 13.0 View
Blood ketone body increased None Investigations MedDRA 13.0 View
Blood lactate dehydrogenase increased None Investigations MedDRA 13.0 View
Blood triglycerides increased None Investigations MedDRA 13.0 View
Blood urine present None Investigations MedDRA 13.0 View
Electrocardiogram abnormal None Investigations MedDRA 13.0 View
Platelet count decreased None Investigations MedDRA 13.0 View
Protein urine present None Investigations MedDRA 13.0 View
Urine output increased None Investigations MedDRA 13.0 View
Weight decreased None Investigations MedDRA 13.0 View
White blood cell count decreased None Investigations MedDRA 13.0 View
Arthropod sting None Injury, poisoning and procedural complications MedDRA 13.0 View
Contusion None Injury, poisoning and procedural complications MedDRA 13.0 View
Foot fracture None Injury, poisoning and procedural complications MedDRA 13.0 View
Joint sprain None Injury, poisoning and procedural complications MedDRA 13.0 View
Muscle strain None Injury, poisoning and procedural complications MedDRA 13.0 View
Open wound None Injury, poisoning and procedural complications MedDRA 13.0 View
Rib fracture None Injury, poisoning and procedural complications MedDRA 13.0 View
Tongue injury None Injury, poisoning and procedural complications MedDRA 13.0 View