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 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT00871351
Description: Randomized participants
Frequency Threshold: 5
Time Frame: None
Study: NCT00871351
Study Brief: Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ezetimibe + Atorvastatin Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg None None 4 47 13 47 View
Atorvastatin Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg None None 1 46 5 46 View
Rosuvastatin Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg None None 0 32 9 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Heat illness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Carcinoid tumour of the gastrointestinal tract SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View