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 @ 10:04 PM
Ignite Modification Date: 2025-12-25 @ 7:40 PM
NCT ID: NCT00513435
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00513435
Study Brief: Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck 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 (Enzyme Inhibitor Therapy) Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. None None 5 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death not assoc w CTCAE term- Sudden death NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Inf norm ANC/gr1/2 neut-Cellulitis(skin) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue (asthenia, lethargy, malaise) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
AST, SGOT SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Neuropathy: sensory SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View