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 |
|---|---|---|---|---|---|---|---|---|
| Treatment: Allogeneic HCT After Reduced Intensity Conditioning | Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV | 2 | None | 2 | 3 | 1 | 3 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diffuse Alveolar Hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| GVHD | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |