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: 2025-12-25 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 2:59 AM
NCT ID: NCT01900002
Description: None
Frequency Threshold: 1
Time Frame: adverse events were collected up to 4 years
Study: NCT01900002
Study Brief: Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
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 (Sorafenib Tosylate, TheraSphere) Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. 0 None 11 34 27 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatic Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Duodenal Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Rectal Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Weakness SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Hypertenstion SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Palmar-Planta Erythrodysesthesia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
ALT increase SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
AST increase SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View