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 1g Per Day x 2 Days | Study participants will be given 1 g placebo prepared as tea for a total of 2 consecutive daily doses. | 0 | None | 0 | 0 | 0 | 0 | View |
| Placebo 1g Per Day x 3 Days | Study participants will be given 1 g of placebo prepared as tea for a total of 3 consecutive daily doses. | 0 | None | 0 | 2 | 0 | 2 | View |
| Placebo 1g Per Day x 1 Day | Study participants will be given 1 g of placebo prepared as tea for a total of 1 daily dose. | 0 | None | 0 | 0 | 0 | 0 | View |
| Kansui 1g Per Day x 1 Day | Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily | 0 | None | 0 | 2 | 0 | 2 | View |
| Kansui 1g Per Day x 2 Days | Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 2 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily | 0 | None | 0 | 0 | 0 | 0 | View |
| Kansui 1g Per Day x 3 Days | Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily | 0 | None | 0 | 1 | 0 | 1 | View |