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 @ 9:10 PM
Ignite Modification Date: 2025-12-25 @ 7:00 PM
NCT ID: NCT00134004
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00134004
Study Brief: Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for 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
Mini-haplo BMT Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. None None 20 210 11 210 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Pulmonary Vascular Obstructive Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Subdural hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Cholestasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Fungemia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Idiopathic pneumonia syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Multi-organ failure SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutropenic fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View