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 |
|---|---|---|---|---|---|---|---|---|
| Patients With Acute Myelogenous Leukemia | Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m\^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses Alternate preparative therapy for patients not able to receive additional radiation Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if \<12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines | None | None | 2 | 3 | 3 | 3 | View |
Serious Events
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| chills | None | General disorders | None | View |
| injection site reaction | None | General disorders | None | View |
| cholecystitis | None | Hepatobiliary disorders | None | View |
| bruising | None | Injury, poisoning and procedural complications | None | View |
| Headache | None | Nervous system disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| pain of skin | None | Skin and subcutaneous tissue disorders | None | View |
| other, rash | None | Skin and subcutaneous tissue disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| other, veno occlusive disease | None | Vascular disorders | None | View |