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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT04342169
Description: We collected AEs that were 1. serious adverse events, 2. non-serious adverse events that are considered by the investigator to be related to study drug or study procedures or of uncertain relationship, and 3. adverse events that lead to permanent discontinuation of the study drug.
Frequency Threshold: 5
Time Frame: Randomization through Day 14 or hospitalization, whichever occurs first.
Study: NCT04342169
Study Brief: University of Utah COVID-19 Hydrochloroquine Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hydroxychloroquine Participants randomized to the HCQ arm will receive HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days. The drug dose (2.4 gm over 5 days) falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of \>20. Hydroxychloroquine: HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days 0 None 9 185 0 185 View
Placebo Those randomized to placebo will receive a placebo to be taken on the same schedule. Placebo oral tablet: Placebo to be taken on the same schedule as HCQ. 0 None 6 183 0 183 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shoulder Arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Acute appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oxygen saturation low SYSTEMATIC_ASSESSMENT Investigations None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diabetic Foot Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypoxic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):