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 @ 7:35 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT00810303
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00810303
Study Brief: Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Group whole study group: 12 healthy subjects None None 0 12 11 12 View
Efavirenz Alone Single Dose None None None 0 12 8 12 View
Ezetimibe Alone Multiple Dose None None None 0 12 3 12 View
Ezetimibe Multiple Dose and Efavirenz Single Dose None None None 0 12 7 12 View
Ezetimibe and Efavirenz Multiple Dose None None None 0 12 7 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Belly ache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Concentration impairment SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Diarrhoea NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Headache NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Hot flushes SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Plasma triglycerides increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Restlessness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Upper abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View