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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT02762266
Description: None
Frequency Threshold: 0
Time Frame: Up to 3 years
Study: NCT02762266
Study Brief: Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transarterial Chemoembolization (TACE) Patients undergo TACE using an embolic agent. 0 None 0 6 6 6 View
Stereotactic Body Radiation Therapy (SBRT) Patients undergo image-guided SBRT. 3 None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
GI disorder other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Hepatic Pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Portal Hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alkaline Phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
ALT SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
AST increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Blood Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
INR increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
WBC decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
None SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View