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: 2025-12-25 @ 3:07 AM
Ignite Modification Date: 2025-12-26 @ 1:47 AM
NCT ID: NCT05259033
Description: Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Frequency Threshold: 5
Time Frame: Week 0 to week 57
Study: NCT05259033
Study Brief: A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IcoSema Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly. 2 None 38 341 163 341 View
Semaglutide Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period. 0 None 21 340 159 340 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acoustic neuroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Cardioversion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 26 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26 View
Colon dysplasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Colorectal adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Migraine without aura SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Optic ischaemic neuropathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Otitis media chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Ovarian adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 26 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Spinal column injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Squamous cell carcinoma of head and neck SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26 View
Squamous cell carcinoma of the tongue SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
VIth nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View