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: 2025-12-25 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 2:00 AM
NCT ID: NCT01524705
Description: None
Frequency Threshold: 0
Time Frame: 34- 36 weeks
Study: NCT01524705
Study Brief: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Insulin Glargine, Metformin, Exenatide Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Exenatide Injectable, 5mcg, BID, 6 months 1 None 4 52 46 52 View
Insulin Glargine, Metformin, Prandial Insulin Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Prandial insulin Aspart or glulisine or lispro 0 None 5 50 37 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrioventricular block second degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Cerebrovascular disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Spondylitic myelopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Stapedotomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Cardiac discomfort NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery thrombosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pancreatic carcinoma metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Human anaplasmosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block second degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Eustachian tube dysfunction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Application site burn NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Device capturing issue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Circumstance or information capable of leading to device use error NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Administration site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Abcess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cojunctiviris NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Accidental overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Conjunctival abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Soft tissue injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tendon injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Compensatory sweating NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Meniscus injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood magnesium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Costochondritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Groin pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tenosynovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cervical radiculopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Prostatitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Menopausal disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Diabetic ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Metatarsal excision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Antiinflammatory therapy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View