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 |
|---|---|---|---|---|---|---|---|---|
| High Viscosity Glass Ionomer Cement (HVGIC) | High Viscosity Glass Ionomer Cement (HVGIC): The MIH affected molar will be restored with HVGIC | 0 | None | 0 | 18 | 0 | 18 | View |
| Silver Diamine Fluoride (SDF) + HVGIC | Silver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC | 0 | None | 0 | 19 | 0 | 19 | View |
| Papain Based Gel + SDF + HVGIC | Papain-Based Gel: Papain based Gel (Papacare Duo) will be applied to the MIH affected molar for 60 seconds and repeated if required. The molar will be treated with SDF and restored using HVGIC | 0 | None | 0 | 20 | 0 | 20 | View |