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 |
|---|---|---|---|---|---|---|---|---|
| Stainless Steel Crown Group | Participants in this group received stainless steel crowns on posterior teeth. Salivary samples were collected before treatment (pre-treatment) and 7 days after treatment. IL-2, IL-5, and IL-17 gene expression levels were measured using Real-Time PCR. Additionally, salivary pH and the concentration of nickel, chrome ions were analyzed using atomic absorption spectrophotometry. Salivary Collection: Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 3-9 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 3 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure. Ph and ion level measurement of saliva: Salivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer. | 0 | None | 0 | 10 | 0 | 10 | View |