Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:42 PM
Ignite Modification Date: 2025-12-25 @ 9:33 PM
NCT ID: NCT02738151
Description: Reported adverse events and death were treatment-emergent adverse events that is adverse events that developed/worsened during the 'on treatment period' (On-treatment period was defined as the time from the first injection of open-label Investigational Medicinal Product (IMP) up to 7 days after the last injection of open-label IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Frequency Threshold: 5
Time Frame: All Adverse Events were collected from signature of the informed consent form until 7 days after last treatment administration (maximum exposure: 24 Weeks).
Study: NCT02738151
Study Brief: Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Toujeo Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. 1 None 21 462 56 462 View
Tresiba Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. 0 None 20 462 58 462 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Coronary Artery Insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Retinal Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Gastric Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Rectal Fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Bacterial Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Meniscus Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Spinal Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Acoustic Neuroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Adenocarcinoma Of Colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Carcinoid Tumour Pulmonary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Pancreatic Carcinoma Metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Ischaemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Trigeminal Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Alcohol Abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Drug Use Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Major Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Interstitial Lung Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Aortic Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Varicose Ulceration SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View