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 @ 3:45 PM
Ignite Modification Date: 2025-12-25 @ 1:53 PM
NCT ID: NCT00469092
Description: The safety analysis population consists of all subjects exposed to trial products.
Frequency Threshold: 5
Time Frame: The adverse event were collected in a time span of 26 weeks.
Study: NCT00469092
Study Brief: Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride 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
BIAsp 30 Biphasic insulin aspart 30 + metformin + glimepiride None None 13 231 56 231 View
Glargine Insulin glargine + metformin + glimepiride None None 10 238 63 238 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Gastroenteritis Escherichia Coli SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Otitis Media Chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Perianal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Vascular Graft Occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.0) View
Diabetic Foot SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.0) View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.0) View
Hypoglycaemic Unconsciousness SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.0) View
Dupuytren's Contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Guillain-Barre Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Hypoglycaemic Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Acute Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Wart Excision SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Arterial Thrombosis Limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Biliary Colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (11.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Pneumonia Primary Atypical SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Postoperative Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Femoral Neck Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View