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 |
|---|---|---|---|---|---|---|---|---|
| Smokers Without COPD | 10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks Losartan 50 mg: 50 mg QD for 4 weeks losartan 100 mg: 50 mg BID for 4 weeks | 0 | None | 0 | 15 | 0 | 15 | View |
| Healthy Non-smokers | 10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks Losartan 50 mg: 50 mg QD for 4 weeks losartan 100 mg: 50 mg BID for 4 weeks | 0 | None | 0 | 16 | 0 | 16 | View |
| Ex-smokers With COPD | 10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks Losartan 50 mg: 50 mg QD for 4 weeks losartan 100 mg: 50 mg BID for 4 weeks | 0 | None | 0 | 0 | 0 | 0 | View |