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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT01674712
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01674712
Study Brief: A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fenofibrate/Simvastatin 145/20 mg Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks None None 3 111 8 111 View
Simvastatin 20 mg Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks None None 3 117 7 117 View
Fenofibrate/Simvastatin 145/40 mg Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks None None 3 113 4 113 View
Simvastatin 40 mg Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks None None 1 115 9 115 View
Fenofibrate 145 mg Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks None None 3 112 15 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACUTE CORONARY SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra View
DIABETES MELLITUS INADEQUATE CONTROL SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra View
TYPE 2 DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra View
LOSS OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra View
VESTIBULAR DISORDER SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDra View
INTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra View
UMBILICAL HERNIA, OBSTRUCTIVE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra View
NON-SITE SPECIFIC INJURIES NEC SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra View
BURSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra View
DIABETES MELLITUS MANAGEMENT SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDra View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.1) View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.1) View
BLOOD CREATINE PHOSPHOKINASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA (15.1) View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.1) View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.1) View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.1) View