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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT00789256
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00789256
Study Brief: Low Dose Melphalan and Bortezomib for AML and High-Risk MDS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Strata 1 Group 1 will include patients who have not seen prior medical intervention for their disease. None None 1 14 14 14 View
Strata 2 will include patients who have received prior medical intervention for their disease. None None 3 12 10 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Legionella Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3.0 View
CNS Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Zoster reactivation SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection NOS SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Generalized weakness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View