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 @ 10:50 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT00074269
Description: AEs and SAEs collected on all Patients
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT00074269
Study Brief: Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer
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 The events monitored in the treatment arm of the protocol are listed below: incidence of Toxicity administration of filgrastim Grade of GVHD Initiation of graft-versus-tumor induction therapy Disease Status 3 None 0 5 5 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
aGVHD Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
aGVHD Gut NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
aGVHD Liver NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Overall GVHD NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
ALT Elevation NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
AST Elevation NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial Effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Capillary Leak Syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bilteral Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View