Adverse Events Module

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 @ 11:34 PM
Ignite Modification Date: 2025-12-25 @ 9:23 PM
NCT ID: NCT02685956
Description: This is a remnant sample study using leftover HSV swab sample media. All case data was fully monitored on completion of the testing phase of the study and no adverse events associated with study subjects contributing biospecimens were identified.. There was also reporting mechanism in place to record device user adverse events however no in vitro diagnostic device user adverse events were reported in the study
Frequency Threshold: 0
Time Frame: This trial utilized remnant laboratory specimens and all results were monitored for accuracy and adverse events upon the completion of the testing phase of the study.
Study: NCT02685956
Study Brief: Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Lesions Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection. 0 None 0 0 0 0 View
Anogenital Lesions Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):