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: 2025-12-26 @ 2:39 PM
Ignite Modification Date: 2025-12-26 @ 2:39 PM
NCT ID: NCT04870606
Description: If an event is not an AE per definition, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). Hospitalizations related to routine treatment or monitoring of the studied indication, not associated with any deterioration in condition should not be reported as SAEs.
Frequency Threshold: 0.5
Time Frame: Up to day 42; the investigator (and/or designee) documented all AEs reported by the subject from the time subjects given consent through completion of the EOS visit (day42) per protocol
Study: NCT04870606
Study Brief: Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GT0918+ Standard of Care Proxalutamide (GT0918): Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory 0 None 0 365 19 365 View
Placebo+ Standard of Care Placebo: Placebo+Standard of care determined by PI and local regulatory 1 None 0 365 11 365 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Paraesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Fibrin D dimer increased NON_SYSTEMATIC_ASSESSMENT Investigations None View