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 @ 7:50 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT02648204
Description: A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Frequency Threshold: 5
Time Frame: Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days)
Study: NCT02648204
Study Brief: Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects 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
Semaglutide 1.0 mg Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. 1 None 23 300 134 300 View
Dulaglutide 0.75 mg Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. 2 None 24 299 106 299 View
Dulaglutide 1.5 mg Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. 2 None 22 299 139 299 View
Semaglutide 0.5 mg Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). 0 None 17 301 132 301 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19 View
Acute vestibular syndrome SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19 View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Cardioversion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Congestive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Cystocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19 View
Diabetic complication SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19 View
Drowning SYSTEMATIC_ASSESSMENT General disorders MedDRA 19 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19 View
Gallbladder pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19 View
Gastrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19 View
Gastroduodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
HIV infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19 View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19 View
Hospitalisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19 View
Hypoglycaemic unconsciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19 View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19 View
Lipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19 View
Malignant neoplasm of ampulla of Vater SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19 View
Metastatic squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 19 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19 View
Orchidectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19 View
Pancreatic carcinoma stage IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Pancreatolithiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Post procedural myocardial infarction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Rectal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19 View
Rectal prolapse SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19 View
Sarcoidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19 View