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 |
|---|---|---|---|---|---|---|---|---|
| Resectable, Low Risk | Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor | 0 | None | 0 | 1 | 0 | 1 | View |
| Locally Advanced | Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor | 1 | None | 3 | 10 | 2 | 10 | View |