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 |
|---|---|---|---|---|---|---|---|---|
| Budesonide Hydrofluoroalkane (HFA) 100 | Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks | None | None | 0 | 86 | 0 | 86 | View |
| Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | None | None | 1 | 81 | 0 | 81 | View |
| Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | None | None | 2 | 85 | 0 | 85 | View |
| Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks | None | None | 0 | 79 | 0 | 79 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oral Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 10.0 | View |
| Respiratory Tract Infection Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 10.0 | View |
| Lower Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 10.0 | View |