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 @ 1:16 AM
Ignite Modification Date: 2025-12-25 @ 11:25 PM
NCT ID: NCT04204993
Description: Adverse event data was collected by observations and reports from study participants.
Frequency Threshold: 5
Time Frame: Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Study: NCT04204993
Study Brief: Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)
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: Influenza A Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation. Lumee Oxygen Platform: Two sensors were inserted (one in the skin of the upper arm and one on the side of the chest). A wireless patch reader was placed on top of the skin over the area where the sensor was placed to measure local oxygen content. 0 None 0 20 9 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dental issue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Foot injury NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
COVID symptoms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cystoscopy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rhinovirus positive NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View