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 |
|---|---|---|---|---|---|---|---|---|
| HSCT | Subjects receive the preparative regimen in 2 steps. The "first step" will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the "first step" of the transplant graft - the donor lymphocytes. The "second step" of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the "second step" of the transplant graft - the stem cells. Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant. Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine Cellular Infusions: Subjects will receive the cellular | None | None | 1 | 2 | 2 | 2 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal cramps | None | General disorders | None | View |
| Abdominal pain | None | General disorders | None | View |
| Back pain | None | General disorders | None | View |
| Bone pain | None | General disorders | None | View |
| CMV reactivation | None | Immune system disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Elevated liver enzymes | None | Hepatobiliary disorders | None | View |
| Erythema | None | Skin and subcutaneous tissue disorders | None | View |
| Fever | None | General disorders | None | View |
| Hyperbilirubinemia | None | Blood and lymphatic system disorders | None | View |
| Leg pain | None | General disorders | None | View |
| Lethargy | None | General disorders | None | View |
| Malaise | None | General disorders | None | View |
| Migraine | None | General disorders | None | View |
| Nausea | None | General disorders | None | View |
| Pruritis | None | Skin and subcutaneous tissue disorders | None | View |
| Tingling in fingers/toes | None | General disorders | None | View |
| Vaginal hemorrhage | None | Reproductive system and breast disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |