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 |
|---|---|---|---|---|---|---|---|---|
| Hypovitaminosis- Vitamin D Group | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D. | 0 | None | 0 | 50 | 0 | 50 | View |
| Hypovitaminosis- Placebo Group | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D. | 0 | None | 0 | 50 | 0 | 50 | View |
| Normovitaminosis | Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study. | 0 | None | 0 | 13 | 0 | 13 | View |