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 |
|---|---|---|---|---|---|---|---|---|
| Kava Pharmacokinetics Single Dose Group | 5 subjects will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over a twelve hour period following administration of kava. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs. | 0 | None | 0 | 5 | 0 | 5 | View |
| Kava Pharmacokinetics 3x a Day Dose Group | 5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs | 0 | None | 0 | 5 | 1 | 5 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Itching two days post dose | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |