Adverse Events Module

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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

Ignite Creation Date: 2025-12-24 @ 9:09 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT00049504
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00049504
Study Brief: Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Nonmyeloablative HSCT) NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1. TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35. 30 None 11 55 55 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Graft-versus-host disease NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Secondary myeloid malignancy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diffuse alveolar hemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Invasive Fungal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV reactivation NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Recurrent or progressive malignancy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View