Study: NCT01458561

Adverse event: Recurrence of Hepatocellular Carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Control subject, recurrence of hepatocellular carcinoma. Treatment of TACE with Cisplatin 12mg/Doxorubicin 12mg. Deemed as grade 2 (moderate) in severity, not related to either the study device or procedure. Event resolved with treatment.
Frequency: 1 affected / 1 at risk

Adverse event: Abdominal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Abnormal Monocyte Count
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Elevated Total Protein
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Hepatic Nodules
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1 at risk

Adverse event: High ALT
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: High Fibrinogen
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: High GGTP
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: High LDH
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: High WBC
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Incisional Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Intermittent Changes in Neutrophil Count (High)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Liver Function Tests Elevated ALT & AST
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low Bilirubin, Total
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low Calcium
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low Cholesterol
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low Creatinine
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low HGB
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low Lipase
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low Pancreatic Amylase
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low Phosphorus
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low Sodium
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Low WBC
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Lower Extremity Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: Worsened Baseline Low HCT
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Worsened Baseline Low RBC
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk