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 @ 10:30 PM
Ignite Modification Date: 2025-12-25 @ 8:03 PM
NCT ID: NCT00045435
Description: None
Frequency Threshold: 0
Time Frame: AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Study: NCT00045435
Study Brief: Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Nonmyeloablative Donor PBSC Transplant) Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27. Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant Fludarabine phosphate: Given IV Total-body irradiation: Undergo total-body irradiation Cyclosporine: Given PO Mycophenolate mofetil: Given PO Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant None None 5 17 4 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
GVHD SYSTEMATIC_ASSESSMENT Immune system disorders None View
Secondary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View