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 @ 11:48 PM
Ignite Modification Date: 2025-12-25 @ 9:42 PM
NCT ID: NCT00853151
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00853151
Study Brief: A Study to Test the Combination of Two Different Kinds of Medications for the Treatment of 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
LY2428757 Plus TT223 3mg Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks None None 2 38 23 38 View
LY2428757 Plus TT223 2mg Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks None None 1 37 29 37 View
LY2428757 Plus TT223 Placebo Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks None None 0 38 26 38 View
LY Placebo Plus TT223 Placebo Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks None None 2 18 12 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA12.0 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA12.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA12.0 View
Ischaemic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA12.0 View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA12.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA12.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA12.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA12.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA12.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA12.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA12.0 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA12.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA12.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA12.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA12.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA12.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA12.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA12.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA12.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA12.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA12.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA12.0 View