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 @ 4:54 PM
Ignite Modification Date: 2025-12-25 @ 2:36 PM
NCT ID: NCT03596450
Description: An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product or medical device, which does not necessarily have to have a causal relationship to the product or device. The safety population includes all randomized patients initiated on study drug.
Frequency Threshold: 5
Time Frame: Up to year 2 (week 104)
Study: NCT03596450
Study Brief: Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Semaglutide Participants received semaglutide subcutaneous (s.c.) injection once weekly in addition to up to 2 oral antidiabetic medications as treatment intensification for 2 years. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants. 9 None 38 634 0 634 View
Standard of Care Participants received standard of care (any commercially available oral or injectable antidiabetic medication, excluding semaglutide) in addition to up to 2 oral antidiabetic medications as treatment intensification for 2 years. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants. 9 None 39 621 0 621 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diabetic nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Accidental death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Abnormal loss of weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Small cell lung cancer extensive stage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Uterine cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Acute haemorrhagic ulcerative colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Pancreatic cyst SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Myasthenia gravis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Visual field defect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Polymyalgia rheumatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21 View
Hypercoagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21 View
Breast dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Acinar cell carcinoma of pancreas SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Adenocarcinoma pancreas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21 View
Apparent death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21 View
Pre-eclampsia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 21 View
Hospitalisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21 View
Osteomyelitis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Cardiac failure 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
Coronary artery dissection SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Breast cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Gastroenteropancreatic neuroendocrine tumour disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Intraductal proliferative breast lesion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Lung carcinoma cell type unspecified stage III SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Disseminated varicella zoster vaccine virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21 View
Other Events(If Any):