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: 2025-12-26 @ 10:34 AM
Ignite Modification Date: 2025-12-26 @ 10:34 AM
NCT ID: NCT03332628
Description: Through the course of this study adverse events were recorded as reported from the subjects.
Frequency Threshold: 0
Time Frame: Adverse Events were monitored during the 5 days while a subject was completing the study and for three days after study completion.
Study: NCT03332628
Study Brief: Racial/Ethnic Differences in Microneedle Response
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Microneedle Application This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into 3 clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured daily at all sites for 4 consecutive days after microneedle application. The measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis. Microneedle patch: Each patch contains 50 microneedles. 0 None 0 113 1 113 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild Skin reaction to waterproof tape NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View