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 |
|---|---|---|---|---|---|---|---|---|
| Erlotinib | This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy. erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST. | None | None | 0 | 2 | 1 | 2 | View |