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 @ 11:02 PM
Ignite Modification Date: 2025-12-25 @ 8:32 PM
NCT ID: NCT04707469
Description: Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Frequency Threshold: 5
Time Frame: Week 0 to week 73
Study: NCT04707469
Study Brief: Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People 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
Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68. 2 None 53 534 277 534 View
Oral Semaglutide 25 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68. 6 None 57 534 294 534 View
Oral Semaglutide 50 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68. 2 None 44 534 314 534 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cystocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Diabetic gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Diabetic metabolic decompensation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
Enterocele SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Epididymitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Epiretinal membrane SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Gallbladder disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Greater trochanteric pain syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Gynaecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Hepatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Iliac artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Intervertebral disc injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Intestinal pseudo-obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Ischaemic skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Keratoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Myelopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Nasal turbinate hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Non-alcoholic steatohepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Pancreatic carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Papilloedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Prostatic adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Renal hypertension SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Renal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Somatic symptom disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Splenic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Swelling face SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Tendon disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Vascular graft occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cellulitis pharyngeal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Abscess intestinal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Abscess oral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Acute left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Aortic valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Brachial plexus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Carotid artery occlusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Cataract subcapsular SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Central nervous system lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Cervical spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Chronic coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Chronic lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Chronic myelomonocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Colon neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View