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 |
|---|---|---|---|---|---|---|---|---|
| Participants Scanned at Baseline & After Chemotherapy | Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B. Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans | 3 | None | 0 | 8 | 1 | 8 | View |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected fine-needle aspiration: sample collected | 5 | None | 0 | 21 | 1 | 21 | View |