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 @ 5:48 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT00390468
Description: The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.
Frequency Threshold: 5
Time Frame: 14 months
Study: NCT00390468
Study Brief: Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tandutinib (MLN518) 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases None None 6 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
platelet count low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
infection with normal ANC SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
pulmonary obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Cranial Nerve III SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
hemmorhage GU urinary NOS SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View