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 @ 6:38 PM
Ignite Modification Date: 2025-12-25 @ 4:08 PM
NCT ID: NCT00427557
Description: None
Frequency Threshold: 1
Time Frame: 10 Years and 3 Months
Study: NCT00427557
Study Brief: Cellular Therapy With Cord Blood Cells
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cellular Therapy With Cord Blood Cells Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion None None 4 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Graft Failure SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Ischemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Graft vs Host Disease SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Blurry Vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Thrombotic Thrombocytopenia Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Low Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Hemolytic Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Elevated Liver Function Tests SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Veno Occulusive Disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Encephalopathy SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Diffuse Alveolar Hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Delayed Engraftment SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fluid Overload SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
GastrointestinaI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhagic Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View