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 @ 2:35 PM
Ignite Modification Date: 2025-12-25 @ 1:07 PM
NCT ID: NCT03198559
Description: All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
Frequency Threshold: 0
Time Frame: Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
Study: NCT03198559
Study Brief: Combination Latency Reversal With High Dose Disulfiram Plus Vorinostat in HIV-infected Individuals on ART
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Participants current ART regimen: 2 grams disulfiram by mouth per day for a total of 28 days 400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24 Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24. 2 None 2 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Altered mental status, Grade 3 SYSTEMATIC_ASSESSMENT Nervous system disorders DAIDS v2 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lethargy, all grades SYSTEMATIC_ASSESSMENT Nervous system disorders DAIDS v2 View
Alanine aminotransferase elevated, Grade 1 SYSTEMATIC_ASSESSMENT Investigations DAIDS v2 View
Diarrhea, grade 1 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders DAIDS v2 View
Hematuria, grade 1 SYSTEMATIC_ASSESSMENT Investigations DAIDS v2 View
Dysgeusia, grade 1 SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v5.0 View
thrombosis or embolism, grade 2 SYSTEMATIC_ASSESSMENT Cardiac disorders DAIDS v2 View
Fatigue, all grades SYSTEMATIC_ASSESSMENT General disorders DAIDS v2 View
Flu like symptoms, grade 2 SYSTEMATIC_ASSESSMENT General disorders DAIDS v2 View