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 |
|---|---|---|---|---|---|---|---|---|
| Single Arm | Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles Conventional surgery : Surgical removal of tumor for correlative studies reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles Microarray analysis : Analysis of tumor for pathologic response to protocol therapy Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles | None | None | 25 | 29 | 0 | 29 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Grade 3 Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Grade 4 Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Grade 3 Febrile Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Grade 3Thrombocytopenia | None | Blood and lymphatic system disorders | None | View |
| Grade 3 Fatigue | None | General disorders | None | View |
| Grade 3 Diarrhea | None | Gastrointestinal disorders | None | View |
| Grade 3 Deep Venous Thrombosis | None | General disorders | None | View |
| Grade 3 Nausea | None | General disorders | None | View |