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 |
|---|---|---|---|---|---|---|---|---|
| OraPlus | During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day. | None | None | 1 | 23 | 0 | 23 | View |
| Simvastatin Susp | Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension. | None | None | 0 | 23 | 0 | 23 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Muscle Pain and Elevated CK | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Serious | View |