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 @ 6:58 PM
Ignite Modification Date: 2025-12-25 @ 4:31 PM
NCT ID: NCT00448357
Description: Additional toxicities were not captured as this was a high-dose transplant study and grades 1, 2 and 3 AEs were generally expected and no unexpected toxicities were seen beyond those reported as SAEs
Frequency Threshold: 5
Time Frame: Mortality was assessed at one year
Study: NCT00448357
Study Brief: Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: GVHD Prophylaxis Experimental: GVHD prophylaxis Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine . Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus. 15 None 26 54 54 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
BK cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Liver Failiure NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Gr 4 GVHD NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gr 4 mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Veno-occlusive disease NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Aspergillus pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV pneumonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Graft Failure NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diffuse alveolar hemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
renal Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
left neck hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Glucose Intolerance NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
grade 3 or 4 hematologic toxicities (expected) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
grade 3 GI toxicity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View