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 | Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days. Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo. | None | None | 0 | 55 | 0 | 55 | View |
| High Dose Broccoli Sprout | Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo. | None | None | 0 | 25 | 0 | 25 | View |
| Medium Dose Broccoli Sprout | Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo. | None | None | 0 | 35 | 0 | 35 | View |
| Low Dose Broccoli Sprout | Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo. | None | None | 0 | 55 | 0 | 55 | View |