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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:55 PM
NCT ID: NCT00582894
Description: None
Frequency Threshold: 1
Time Frame: Day 100 Post Transplant
Study: NCT00582894
Study Brief: Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reduced Intensity Regimen Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 None None 1 17 4 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intracranial hemorrhage - recurrence NON_SYSTEMATIC_ASSESSMENT Vascular disorders Source Vocabulary View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Positive Cytomegalovirus cultures NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Source Vocabulary View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Source Vocabulary View
Blasts in bone marrow NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Source Vocabulary View
Syncopal episode / Hypotension NON_SYSTEMATIC_ASSESSMENT General disorders Source Vocabulary View