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 @ 11:41 PM
Ignite Modification Date: 2025-12-25 @ 9:32 PM
NCT ID: NCT05305651
Description: All-cause mortality, Treatment-emergent serious adverse events (TESAEs) and Treatment-emergent non-SAEs were reported for the Safety Set (Safety Set included all participants who were enrolled and exposed to study intervention).
Frequency Threshold: 0
Time Frame: Up to Day 28
Study: NCT05305651
Study Brief: Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sotrovimab 500 mg IV Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19). 1 None 0 217 6 217 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 26.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 26.0 View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.0 View
Anosmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 26.0 View