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 @ 6:28 PM
Ignite Modification Date: 2025-12-25 @ 3:58 PM
NCT ID: NCT00796068
Description: None
Frequency Threshold: 0
Time Frame: Adverse events (AE) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational product in this study through day +100 post-transplant. The start of the adverse event reporting for a study subject will coincide with signing of the informed consent. All-cause mortality data was censored at two-year follow-up.
Study: NCT00796068
Study Brief: Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (Low Risk for Graft Failure) Patients receive a conditioning regimen comprising fludarabine phosphate IV over 1 hour every day (QD) on days -6 to -2 and treosulfan IV over 120 minutes on days - 6 to -4. Patients undergo (total body irradiation (TBI) on day -1. Patients then undergo donor cord blood transplantation (CBT) on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising cyclosporine IV over 1 hour or by mouth (PO) 2-3 times daily on days -3 to 100, followed by a taper in the absence of GVHD. Patients also receive mycophenolate mofetil IV 3 times daily on days 0 to 40, followed by a taper in the absence of GVHD. Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV Total-Body Irradiation: TBI administered day -1: 200 centigray (cGy) (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section) Treosulfan: Given IV Umbilical Cord Blood Transplantation (UCBT): Undergo single or double unit UCBT 16 None 27 66 63 66 View
Arm II (High Risk for Graft Failure) Patients receive a conditioning regimen, TBI, donor UCBT, GVHD prophylaxis, and mycophenolate mofetil as in Arm I. Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV Total-Body Irradiation: TBI administered day -1: 200 cGy (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section) Treosulfan: Given IV Umbilical Cord Blood Transplantation: Undergo single or double unit UCBT 20 None 23 64 59 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Acute cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left Ventricular Systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Infusional Toxicity/Stunned Heart SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinusoidal obstruction syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Myelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other - autonomic dysreflexia exacerbation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Encephalitis infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Disemminated vascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sinusoidal obstruction syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Rash maculopapular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gatritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Otitis Externa SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Duodenal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Encephalitis infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Left Ventricular Systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oral cavity SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other: genitourinary SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other: pulmonary insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other: Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other: Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other: Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other: Genitalia infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other: Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View