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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT05109104
Description: AEs, and therefore all serious adverse events (SAEs), were to be collected from immediately after a participant provided written consent to participate in the trial until 14 days after the last administration of study treatment (or the last study procedure). All SAEs were to be reported within 24 hours of detection. Localized erythema caused by exposure of the skin to UV radiation is expected and was not reported as an adverse event.
Frequency Threshold: 0
Time Frame: From screening until 14 days after last dose administration of trial product (Up to 16 days)
Study: NCT05109104
Study Brief: Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three Sunscreen Products
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPF Standard (CAP Mountain Berry Dataset) All participants with valid data for SPF Standard (CAP Mountain Berry dataset). 0 None 0 13 0 13 View
SPF Standard (CAP Herbal Mint Dataset) All participants with valid data for SPF Standard (CAP Herbal Mint dataset). 0 None 0 11 0 11 View
CAP Mountain Berry All participants with valid data for CAP Mountain Berry. 0 None 0 13 0 13 View
CAP UnScented All participants with valid data for CAP UnScented. 0 None 0 11 0 11 View
SPF Standard (CAP UnScented Dataset) All participants with valid data for SPF Standard (CAP UnScented dataset). 0 None 0 11 0 11 View
CAP Herbal Mint All participants with valid data for CAP Herbal Mint. 0 None 0 11 0 11 View
Serious Events(If Any):
Other Events(If Any):