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 @ 4:21 PM
Ignite Modification Date: 2025-12-25 @ 2:17 PM
NCT ID: NCT01070966
Description: None
Frequency Threshold: 5
Time Frame: Year 1 through Year 6. There were no SAE's reported in Year three.
Study: NCT01070966
Study Brief: Vytorin Reexamination Study (0653A-174)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VYTORIN YEAR 5 Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5 None None 0 380 0 380 View
VYTORIN YEAR 1 Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1 None None 0 9 0 9 View
VYTORIN YEAR 2 Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2 None None 4 933 0 933 View
VYTORIN YEAR 4 Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4 None None 6 531 0 531 View
VYTORIN YEAR 6 Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6 None None 5 158 0 158 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
VERTIGO POSITIONAL SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
DIABETIC RETINOPATHY SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
GASTRIC ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
RETROPERITONEAL HAEMATOMA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
CHOLECYSTITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
PYELONEPHRITIS ACUTE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
DIABETIC FOOT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
GOUTY ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
SPINAL COLUMN STENOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
CERVIX CARCINOMA RECURRENT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Other Events(If Any):