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 |
|---|---|---|---|---|---|---|---|---|
| Omiganan 1% Gel (Part 1) | In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen. | None | None | 0 | 25 | 0 | 25 | View |
| Chlorhexidine | In Part 1 each subject had chlorhexidine 2% applied to 6 sites located across the chest and/or abdomen. In Part 2 subjects had chlorhexidine 2%/isopropyl alcohol applied to one intravenous (IV) catheter site. | None | None | 0 | 25 | 7 | 25 | View |
| Omiganan 1% (Part 2) | In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Omiganan 1% gel was applied to one intravenous (IV) catheter site. | None | None | 0 | 25 | 8 | 25 | View |