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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | 1. st visit: For the control group, no treatment will be given. 2. nd visit: 2 weeks after initial visit, patient will be seen for second visit | None | None | 0 | 10 | 0 | 10 | View |
| Treatment | 1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece. 2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece. Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser No patients reported complications or adverse events after 2 sessions. | None | None | 0 | 17 | 0 | 17 | View |