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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT01427504
Description: Adverse events were verbally assessed by study investigators. Laboratory tests were performed at baseline and at all three intensive pharmacokinetic study visits. Clinical and laboratory adverse events were graded using the 2004 Division of AIDS table for grading the severity of adult and pediatric adverse experiences.
Frequency Threshold: 5
Time Frame: 4 months
Study: NCT01427504
Study Brief: Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Boceprevir Alone Subjects took boceprevir alone, 800 mg thrice daily, for 10-14 days. None None 0 21 19 21 View
Etravirine Alone Subjects took etravirine alone, 200 mg twice daily, for 10-14 days None None 1 22 11 22 View
Boceprevir Coadministered With Etravirine Boceprevir, 800 mg thrice daily, coadministered with etravirine, 200 mg twice daily for 10-14 days. None None 5 25 21 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Grade 2 View
Increased energy, anxiety, nervousness, insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders Serious, Mild/Mod View
Presumed Viral Illness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Serious, Mild/Mod View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Altered Taste SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Serious, Mild/Mod View
Headache SYSTEMATIC_ASSESSMENT General disorders Serious, Mild/Mod View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Serious, Mild/Mod View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Serious, Mild/Mod View
Hypokalemia SYSTEMATIC_ASSESSMENT General disorders Serious, Mild/Mod View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Serious, Mild/Mod View