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 |
|---|---|---|---|---|---|---|---|---|
| PegIntron + Rebetol | PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype. | None | None | 4 | 246 | 0 | 0 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Endocarditis | None | Infections and infestations | MedDRA 12.1 | View |
| Pneumonia | None | Infections and infestations | MedDRA 12.1 | View |
| Diabetes mellitus | None | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Convulsion | None | Nervous system disorders | MedDRA 12.1 | View |
| Pregnancy of partner | None | Social circumstances | MedDRA 12.1 | View |