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 @ 6:33 PM
Ignite Modification Date: 2025-12-25 @ 4:03 PM
NCT ID: NCT00506857
Description: None
Frequency Threshold: 1
Time Frame: March 2000 to December 2004 (4 years, 8 months)
Study: NCT00506857
Study Brief: Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Busulfan + Fludarabine Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days. None None 72 80 80 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Graft failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Diffuse alveolar haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Acute Graft versus Host Disease SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Chronic Graft versus Host Disease SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Elevated alanine aminotransferase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Hemorrhagic cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Elevated alkaline phosphate SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Occular SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Lethargy SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Stomatitis/Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Elevated alanine aminotransferase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View