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 @ 1:32 AM
Ignite Modification Date: 2025-12-25 @ 11:45 PM
NCT ID: NCT01128894
Description: SAEs and AEs were collected in members of the Safety Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Frequency Threshold: 2
Time Frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring while participants were on treatment up until 56 days after the last dose (up to Week 40), are reported.
Study: NCT01128894
Study Brief: A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Albiglutide 50 mg Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6. None None 20 404 266 404 View
Liraglutide 1.8 mg Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg. None None 23 408 289 408 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Blood amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Encephalitis herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ileus SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Burns first degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View