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 @ 11:17 PM
Ignite Modification Date: 2025-12-25 @ 8:56 PM
NCT ID: NCT00576056
Description: Regular investigator assessment and laboratory testing in addition to participant self reporting
Frequency Threshold: 0
Time Frame: None
Study: NCT00576056
Study Brief: Effectiveness and Safety Study of TACE Plus Oral Sorafenib for Unresectable HCC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tace + Sorafenib Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment. TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination. None None 1 19 7 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased ALT SYSTEMATIC_ASSESSMENT Investigations None View
Increased AST SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased GGTP SYSTEMATIC_ASSESSMENT Investigations None View
leukopenia SYSTEMATIC_ASSESSMENT Investigations None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
Increased total bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiccups SYSTEMATIC_ASSESSMENT General disorders None View
Increased Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations None View
Increased Lipase SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Muscle Aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tremors SYSTEMATIC_ASSESSMENT General disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mouth Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased Serum Albumin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Breast Tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bleeding oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Difficulty swallowing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bleeding varices SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower Extremity Edema SYSTEMATIC_ASSESSMENT General disorders None View
Incisional hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated Amylase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View