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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT02971735
Description: Because no previous adverse event of e-learning had been reported, we collected possible adverse event data using an anonymous qualitative feedback questionnaire.
Frequency Threshold: 0
Time Frame: We collected adverse event data 7 days after intervention.
Study: NCT02971735
Study Brief: Cognitive Style and Mobile Technology in E-learning in Undergraduate Medical Education
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Interactive Multimedia Module Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the interactive multimedia (IM) module consist of integrated text, images, and small game tests (intervention) for 100 minutes. The module is a non-linearity of learning with interaction (student-based choice and pop-up feedback). This context has been adjusted to the same level to that of the PPS module. mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module. 0 None 0 30 0 30 View
Power Point Show Module Subjects allocated to this experimental group will receive an intervention of mobile technology of e-learning (M-TEL) using the Power Point show (PPS) module consist of integrated text, images, and audio (intervention) for 100 minutes. The module is a linear learning without interaction. This context has been adjusted to the same level to that of the IM module. mobile technology of e-learning (M-TEL): UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module. 0 None 0 30 0 30 View
Serious Events(If Any):
Other Events(If Any):