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 @ 12:23 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT04074161
Description: All presented AEs are treatment-emergent (i.e., TEAEs). TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. Results are based on the SAS which included all randomized participants exposed to at least one dose of randomized treatment.
Frequency Threshold: 5
Time Frame: From week 0 to week 75
Study: NCT04074161
Study Brief: Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
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 2.4 mg The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment. 0 None 10 126 115 126 View
Liraglutide 3.0 mg The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment. 0 None 14 127 115 127 View
Pooled Placebo Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment. 0 None 6 85 68 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Uterine enlargement SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23 View
Viral sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Bradyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Cardiac ablation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 23 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23 View
Clear cell renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Foot deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Invasive lobular breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Lactose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Lumbar radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Post procedural drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 23 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View