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 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:54 AM
NCT ID: NCT02501161
Description: All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
Frequency Threshold: 5
Time Frame: Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
Study: NCT02501161
Study Brief: A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
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 Degludec/Liraglutide Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). 2 None 60 506 206 506 View
Insulin Glargine Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. 5 None 43 504 156 504 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Cervicobrachial syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Coronary arterial stent insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Gastroduodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Lung perforation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Peripheral arterial reocclusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Postoperative respiratory failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Stab wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Tympanoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Uterine cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Vasoconstriction SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Vertebrobasilar insufficiency SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Benign hepatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Dacryocystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21 View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Helicobacter gastritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Ilium fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Oesophageal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Ovarian cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Percutaneous coronary intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Respiratory fume inhalation disorder SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View