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 |
|---|---|---|---|---|---|---|---|---|
| Generic Clopidogrel Product | Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days -Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 | None | None | 0 | 31 | 0 | 31 | View |
| Original Clopidogrel Product | Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days -Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 | None | None | 0 | 31 | 0 | 31 | View |