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 @ 2:25 PM
Ignite Modification Date: 2025-12-25 @ 1:00 PM
NCT ID: NCT00664859
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00664859
Study Brief: 12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atorvastatin 40 mg Data presented by previous double-blind study assignment 0 None 1 45 21 45 View
LCP-AtorFen 40/100mg Data presented by previous double-blind study assignment 0 None 3 51 12 51 View
Fenofibrate 145 mg Data presented by previous double-blind study assignment 0 None 3 44 21 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Rectal cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Fracture treatment NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated ALT NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View