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: 2025-12-25 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:03 AM
NCT ID: NCT00301834
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00301834
Study Brief: Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm - Transplant Pre-conditioning Per Study Protocol All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done. None None 7 35 33 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
aGVHD (acute Graft-Versus-Host Disease) SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory distress associated with Cytomegalovirus infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pancytopenia and splenomegaly NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Repiratory failure following ideopathic pneumonia syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Aspergillus pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Graft rejection/failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Viral Encephalitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Massive intracranial bleed NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mucositis (All grades) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
aGVHD SYSTEMATIC_ASSESSMENT General disorders None View
cGVHD (Chronic graft-versus-host disease) SYSTEMATIC_ASSESSMENT General disorders None View
Infusion reaction to alemtuzumab SYSTEMATIC_ASSESSMENT General disorders None View