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 |
|---|---|---|---|---|---|---|---|---|
| Desloratadine 5 mg | Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks | None | None | 0 | 80 | 10 | 80 | View |
| Desloratadine 10 mg | Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks | None | None | 0 | 79 | 8 | 79 | View |
| Placebo | Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks | None | None | 0 | 79 | 5 | 79 | View |
| Desloratadine 5 mg→Placebo | Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week | None | None | 0 | 1 | 0 | 1 | View |