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 |
|---|---|---|---|---|---|---|---|---|
| Danoprevir,Ritonavir, Peg-IFN,RBV | Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks. Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily Ritonavir: Ritonavir 100mg tablet administered orally twice daily peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) | None | None | 1 | 70 | 70 | 70 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| acute pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |