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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT02229227
Description: On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Frequency Threshold: 5
Time Frame: Up to 26 weeks
Study: NCT02229227
Study Brief: Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
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 + Insulin Glargine During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period. 0 None 23 400 114 400 View
Insulin Lispro + Insulin Glargine During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period. 1 None 31 413 101 413 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Teratoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Conductive deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.1 View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.1 View
Uterine polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.1 View
Angle closure glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Brain stem infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Peripheral artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Mesenteric artery stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Perineal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View