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: 2025-12-25 @ 12:03 AM
Ignite Modification Date: 2025-12-25 @ 10:02 PM
NCT ID: NCT00104858
Description: Historical controls were utilized for comparison
Frequency Threshold: 0
Time Frame: AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Study: NCT00104858
Study Brief: Fludarabine Phosphate, Radiation Therapy, and Rituximab in Treating Patients Who Are Undergoing Donor Stem Cell Transplant Followed by Rituximab for High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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 Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and rituximab IV on days -3, 10, 24, and 38. Patients undergo single fraction low-dose TBI on day 0. After completion of TBI, patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive rituximab IV on days 10, 24, and 38. Patients receive an immunosuppressive regimen comprising cyclosporine PO BID on days -3 to 56 followed by a taper to day 180 (related recipients) or on days -3 to 100 followed by a taper to day 180 (unrelated recipients). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related recipients) or TID on days 0-40 followed by a taper to day 96 (unrelated recipients). Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT Cyclosporine: Given PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: 33 None 4 52 22 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death related to grade 4 GVHD SYSTEMATIC_ASSESSMENT Immune system disorders None View
Death-septic shock related to acute GVHD SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrombotic microangiopathy, secondary to cyclosporine, resulting in renal failure requiring dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Volume overload likely precipitating hypoxia and heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest CT show filling defect that consistent with pulmonary embolism SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncopal episode with neurological exam and head CT unremarkable SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Decrease in LVEF from 55% to 24% due to volume overload SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sharp left sided chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Weight gain associated with pleural effusion SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection (Bacterial & Fungal) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncopal episode SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Systemic inflammatory response syndrome (SIRS) SYSTEMATIC_ASSESSMENT Infections and infestations None View