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 |
|---|---|---|---|---|---|---|---|---|
| Perlane-L | Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%. | None | None | 0 | 60 | 60 | 60 | View |
| Perlane | Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%. | None | None | 0 | 60 | 60 | 60 | View |