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: 2025-12-25 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT02404805
Description: AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/.
Frequency Threshold: 5
Time Frame: Time of consenting to study exit (Phone follow up 7 days after final intensive PK visit, max 3 months)
Study: NCT02404805
Study Brief: Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative 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
Simeprevir Only Simeprevir tablets 150mg, once daily x 7 days. 0 None 0 25 4 25 View
Dolutegravir Only Dolutegravir tablets 50mg, once daily x 7 days. 0 None 0 24 7 24 View
Dolutegravir and Simeprevir Co-administered: Dolutegravir and simeprevir co-administered: dolutegravir tablets 50mg, once daily, and simeprevir tablets 150mg, once daily, x 7 days 0 None 0 24 10 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal issues (stomach pain, gas, vomiting, nausea, diarrhea) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abnormal Labs SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View