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 @ 4:04 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT01414166
Description: The safety population consisted of all participants that received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
Study: NCT01414166
Study Brief: Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ERN/LPRT Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk. None None 1 120 42 120 View
Placebo Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk. None None 0 121 17 121 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Impaired Fasting Glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View