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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Microneedle Pretreatment | One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points. Microneedle Roller: 200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller Topical 4% lidocaine | 0 | None | 0 | 21 | 0 | 21 | View |
| Sham Microneedle Pretreatment | One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points. Sham microneedle Roller: Flat roller without microneedles Topical 4% lidocaine | 0 | None | 0 | 21 | 0 | 21 | View |