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: 2025-12-24 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT01413204
Description: None
Frequency Threshold: 0
Time Frame: 26 weeks
Study: NCT01413204
Study Brief: Efficacy and Safety Study of 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
Placebo TA-7284 Placebo, once daily for 24 weeks None None 2 93 54 93 View
TA-7284 Low TA-7284 low dose, once daily for 24 weeks None None 1 90 59 90 View
TA-7284 High TA-7284 high dose, once daily for 24 weeks None None 1 89 55 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15 View
Gastric cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Hepatic neoplasm malignant None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Oropharyngeal cancer stage unspecified 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
Other Events(If Any):

Other Events

Term Type Organ System Vocab 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
Acute tonsillitis None Infections and infestations MedDRA 15 View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA 15 View
Asteatosis None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Asthenia None General disorders MedDRA 15.0 View
Back pain None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Bacteriuria None Infections and infestations MedDRA 15.0 View
Balanoposthitis None Reproductive system and breast disorders MedDRA 15.0 View
Benign prostatic hyperplasia None Reproductive system and breast disorders MedDRA 15.0 View
Blister None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Blood creatine phosphokinase increased None Investigations MedDRA 15.0 View
Blood creatinine increased None Investigations MedDRA 15.0 View
Blood ketone body increased None Investigations MedDRA 15.0 View
Blood parathyroid hormone 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
Blood uric acid increased None Investigations MedDRA 15.0 View
Blood urine present None Investigations MedDRA 15.0 View
Bronchitis None Infections and infestations MedDRA 15.0 View
Bursitis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Cervical dysplasia None Reproductive system and breast disorders MedDRA 15.0 View
Cervicobrachial syndrome None Nervous system disorders MedDRA 15.0 View
Chest discomfort None General disorders MedDRA 15.0 View
Chronic sinusitis None Infections and infestations MedDRA 15.0 View
Colonic polyp None Gastrointestinal disorders MedDRA 15.0 View
Conjunctivitis allergic None Eye disorders MedDRA 15.0 View
Constipation None Gastrointestinal disorders MedDRA 15.0 View
Contusion None Injury, poisoning and procedural complications MedDRA 15.0 View
Cystitis None Infections and infestations MedDRA 15.0 View
Dental caries None Gastrointestinal 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
Diarrhoea None Gastrointestinal disorders MedDRA 15.0 View
Diplopia None Eye disorders MedDRA 15.0 View
Dizziness None Nervous system disorders MedDRA 15.0 View
Dizziness postural None Nervous system disorders MedDRA 15.0 View
Dry eye None Eye disorders MedDRA 15.0 View
Dry mouth 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
Enteritis infectious None Infections and infestations MedDRA 15.0 View
Enterocolitis None Gastrointestinal disorders MedDRA 15.0 View
Excoriation None Injury, poisoning and procedural complications MedDRA 15 View
Face injury None Injury, poisoning and procedural complications MedDRA 15.0 View
Fasciitis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Flank pain None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Folliculitis None Infections and infestations MedDRA 15.0 View
Forearm fracture None Injury, poisoning and procedural complications MedDRA 15.0 View
Gamma-glutamyltransferase increased None Investigations 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
Gastroenteritis viral None Infections and infestations MedDRA 15.0 View
Gastrooesophageal reflux disease None Gastrointestinal disorders MedDRA 15.0 View
Gingivitis None Gastrointestinal disorders MedDRA 15.0 View
Gout None Metabolism and nutrition disorders MedDRA 15.0 View
Haemorrhoids None Gastrointestinal disorders MedDRA 15.0 View
Hangover None General disorders MedDRA 15.0 View
Headache None Nervous system disorders MedDRA 15.0 View
Heat rash None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Hepatic function abnormal None Hepatobiliary disorders MedDRA 15.0 View
Herpes virus infection 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
Hot flush None Vascular disorders MedDRA 15 View
Hunger None General disorders MedDRA 15.0 View
Hypertension None Vascular disorders MedDRA 15.0 View
Hypoaesthesia None Nervous system disorders MedDRA 15.0 View
Hypoglycaemia None Metabolism and nutrition disorders MedDRA 15.0 View
Hypoglycaemia unawareness None Metabolism and nutrition disorders MedDRA 15.0 View
Influenza None Infections and infestations MedDRA 15.0 View
Injury corneal None Injury, poisoning and procedural complications MedDRA 15.0 View
Ligament sprain None Injury, poisoning and procedural complications MedDRA 15.0 View
Lumbar spinal stenosis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Migraine None Nervous system disorders MedDRA 15.0 View
Mouth injury None Injury, poisoning and procedural complications 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
Myofascial pain syndrome None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Nasopharyngitis None Infections and infestations MedDRA 15.0 View
Nausea None Gastrointestinal disorders MedDRA 15.0 View
Neck pain None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Nephropathy None Renal and urinary disorders MedDRA 15.0 View
Oral herpes None Infections and infestations MedDRA 15.0 View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Orthostatic hypotension None Vascular disorders MedDRA 15.0 View
Pain in extremity None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Palpitations None Cardiac disorders MedDRA 15.0 View
Pancreatitis acute None Gastrointestinal disorders MedDRA 15.0 View
Periarthritis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Periodontal disease None Gastrointestinal disorders MedDRA 15.0 View
Periodontitis None Gastrointestinal disorders MedDRA 15.0 View
Pharyngitis None Infections and infestations MedDRA 15.0 View
Pharyngitis bacterial None Infections and infestations MedDRA 15.0 View
Pollakiuria None Renal and urinary disorders MedDRA 15.0 View
Polycythaemia None Blood and lymphatic system disorders MedDRA 15.0 View
Post herpetic neuralgia None Nervous system disorders MedDRA 15.0 View
Pulmonary fibrosis None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pulpitis dental None Infections and infestations MedDRA 15.0 View
Punctate keratitis None Eye disorders MedDRA 15.0 View
Pyelonephritis None Infections and infestations MedDRA 15.0 View
Rash None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rhinitis allergic None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Sciatica None Nervous system disorders MedDRA 15.0 View
Seborrhoeic dermatitis None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Skeletal injury None Injury, poisoning and procedural complications MedDRA 15.0 View
Skin fissures None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Spinal compression fracture None Injury, poisoning and procedural complications MedDRA 15.0 View
Spinal osteoarthritis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Stomatitis None Gastrointestinal disorders MedDRA 15.0 View
Tenosynovitis None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Thermal burn None Injury, poisoning and procedural complications MedDRA 15.0 View
Thirst None General disorders MedDRA 15.0 View
Tinea pedis None Infections and infestations MedDRA 15.0 View
Toothache None Gastrointestinal disorders MedDRA 15.0 View
Toxic skin eruption None Skin and subcutaneous tissue disorders MedDRA 15 View
Trigger finger None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Urinary retention None Renal and urinary disorders MedDRA 15.0 View
Urine albumin/creatinine ratio increased None Investigations MedDRA 15.0 View
Urine ketone body present None Investigations MedDRA 15.0 View
Urine output increased None Investigations MedDRA 15.0 View
Vertigo None Ear and labyrinth disorders MedDRA 15.0 View
Vulvitis None Infections and infestations MedDRA 15.0 View
Vulvovaginal candidiasis None Infections and infestations MedDRA 15.0 View
Vulvovaginal mycotic infection None Infections and infestations MedDRA 15.0 View
Weight decreased None Investigations MedDRA 15.0 View