Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:32 PM
Ignite Modification Date: 2025-12-25 @ 7:16 PM
NCT ID: NCT00769132
Description: Although 26 participants were included in the assessment of safety, not all participants received all treatments.
Frequency Threshold: 5
Time Frame: None
Study: NCT00769132
Study Brief: A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(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
ER Niacin 2 g / Laropiprant 40 mg ER niacin 2 g/laropiprant 40 mg once daily for 7 days None None 0 25 15 25 View
ER Niacin 2 g ER niacin 2 g once daily for 7 days None None 0 24 21 24 View
Placebo Placebo once daily for 7 days None None 0 25 5 25 View
Laropiprant 40 mg Laropiprant 40 mg once daily for 7 days None None 0 25 4 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal Disorders None Gastrointestinal disorders MedDRA (10.1) View
Abdominal Pain None Gastrointestinal disorders MedDRA (10.1) View
Constipation None Gastrointestinal disorders MedDRA (10.1) View
Diarrhoea None Gastrointestinal disorders MedDRA (10.1) View
Dry Mouth None Gastrointestinal disorders MedDRA (10.1) View
Nausea None Gastrointestinal disorders MedDRA (10.1) View
Vomiting None Gastrointestinal disorders MedDRA (10.1) View
General Disorders And Administration Site Conditions None Gastrointestinal disorders MedDRA (10.1) View
Musculoskeletal And Connective Tissue Disorders None Musculoskeletal and connective tissue disorders MedDRA (10.1) View
Myalgia None Musculoskeletal and connective tissue disorders MedDRA (10.1) View
Nervous System Disorders None Nervous system disorders MedDRA (10.1) View
Headache None Nervous system disorders MedDRA (10.1) View
Renal And Urinary Disorders None Renal and urinary disorders MedDRA (10.1) View
Skin And Subcutaneous Tissue Disorders None Skin and subcutaneous tissue disorders MedDRA (10.1) View
Pruritus None Skin and subcutaneous tissue disorders MedDRA (10.1) View
Pruritus Generalised None Skin and subcutaneous tissue disorders MedDRA (10.1) View
Vascular Disorders None Vascular disorders MedDRA (10.1) View
Flushing None Vascular disorders MedDRA (10.1) View