Trial Outcomes & Findings for A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) (NCT NCT02821754)

NCT ID: NCT02821754

Last Updated: 2023-03-28

Results Overview

PFS is the median amount of time subject survives without disease progression 6 months after treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: At 6 months
• Results posted on: 2023-03-28

Participant Flow

Two participants were enrolled but not treated. With the exception of baseline data, no other data were collected for these participants.

Participant milestones

Measure	Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE) RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Radiofrequency Ablation/Cryoablation (RFA/CA) Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Enrolled But Not Treated Enrolled but not treated.
Overall Study STARTED	36	16	2
Overall Study COMPLETED	20	4	0
Overall Study NOT COMPLETED	16	12	2

Reasons for withdrawal

Measure	Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE) RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Radiofrequency Ablation/Cryoablation (RFA/CA) Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Enrolled But Not Treated Enrolled but not treated.
Overall Study Procedure not required prior to amendment change	13	11	0
Overall Study Participant's Clinical status	2	0	0
Overall Study Participant removed for noncompliance	1	0	0
Overall Study Drug not available.	0	0	1
Overall Study Participant declined to participate (before treatment started.)	0	1	1

Baseline Characteristics

A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)

Baseline characteristics by cohort

Measure	Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE) n=36 Participants RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Radiofrequency Ablation/Cryoablation (RFA/CA) n=16 Participants Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Enrolled But Not Treated n=2 Participants Enrolled but not treated.	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	12 Participants n=7 Participants	1 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	24 Participants n=4 Participants
Age, Continuous	64.54 years STANDARD_DEVIATION 12.57 • n=5 Participants	57.59 years STANDARD_DEVIATION 14.24 • n=7 Participants	66.1 years STANDARD_DEVIATION 3.25 • n=5 Participants	62.54 years STANDARD_DEVIATION 13.13 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	38 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	16 Participants n=7 Participants	2 Participants n=5 Participants	50 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	16 Participants n=7 Participants	2 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	36 participants n=5 Participants	16 participants n=7 Participants	2 participants n=5 Participants	54 participants n=4 Participants

PRIMARY outcome

Timeframe: At 6 months

PFS is the median amount of time subject survives without disease progression 6 months after treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE) n=36 Participants RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Radiofrequency Ablation/Cryoablation (RFA/CA) n=1 Participants Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation
6 Month Progression Free Survival (PFS)	2.8 Months Interval 1.3 to 4.8	NA Months Only one participant on the radiofrequency ablation/cryoablation group received the cryoablation, thus we cannot do the median on this group.

SECONDARY outcome

Timeframe: 60 days after last treatment, an average of 44.89 months

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4.0. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event.

Outcome measures

Measure	Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE) n=36 Participants RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Radiofrequency Ablation/Cryoablation (RFA/CA) n=16 Participants Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation
Number of Grades 1-5 Adverse Events Related to Tremelimumab and Durvalumab Grade 1	355 adverse events	233 adverse events
Number of Grades 1-5 Adverse Events Related to Tremelimumab and Durvalumab Grade 2	125 adverse events	133 adverse events
Number of Grades 1-5 Adverse Events Related to Tremelimumab and Durvalumab Grade 3	62 adverse events	50 adverse events
Number of Grades 1-5 Adverse Events Related to Tremelimumab and Durvalumab Grade 4	6 adverse events	3 adverse events
Number of Grades 1-5 Adverse Events Related to Tremelimumab and Durvalumab Grade 5	0 adverse events	2 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE) n=36 Participants RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Radiofrequency Ablation/Cryoablation (RFA/CA) n=16 Participants Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	36 Participants	16 Participants

Adverse Events

Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)

Serious events: 20 serious events

Other events: 36 other events

Deaths: 26 deaths

Radiofrequency Ablation/Cryoablation (RFA/CA)

Serious events: 7 serious events

Other events: 16 other events

Deaths: 15 deaths

Serious adverse events

Measure	Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE) n=36 participants at risk RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Radiofrequency Ablation/Cryoablation (RFA/CA) n=16 participants at risk Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation
Gastrointestinal disorders Abdominal pain	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Renal and urinary disorders Acute kidney injury	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Psychiatric disorders Agitation	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Alanine aminotransferase increased	2.8% 1/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Alkaline phosphatase increased	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Immune system disorders Allergic reaction	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Immune system disorders Anaphylaxis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Blood and lymphatic system disorders Anemia	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Ascites	5.6% 2/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Aspartate aminotransferase increased	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Cardiac disorders Atrial fibrillation	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Back pain	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Blood bilirubin increased	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Bullous dermatitis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Cardiac disorders Chest pain - cardiac	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Colitis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Psychiatric disorders Confusion	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Cough	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Dehydration	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Depressed level of consciousness	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Diarrhea	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Dry mouth	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Edema limbs	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Encephalopathy	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Fever	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Gastritis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Hepatobiliary disorders Hepatic hemorrhage	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hyperglycemia	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hyperkalemia	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hyponatremia	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypophosphatemia	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Vascular disorders Hypotension	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Ileal obstruction	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Immune system disorders Immune system disorders - Other, Skin rash near anus	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Infections and infestations - Other, Cellulitis - infection left upper extremity	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Infections and infestations - Other, severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Infections and infestations - Other, biliary stent infection	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Jejunal perforation	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Lung infection	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Mucositis oral	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Myasthenia Gravis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Myalgia	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Myositis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Nausea	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death	8.3% 3/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Pain	8.3% 3/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Pancreatitis	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Platelet count decreased	2.8% 1/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.6% 2/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Pneumonia	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Sepsis	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Stroke	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Cardiac disorders Supraventricular tachycardia	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Vascular disorders Thromboembolic event	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Weight loss	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.

Other adverse events

Measure	Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE) n=36 participants at risk RFA/TACE Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation	Radiofrequency Ablation/Cryoablation (RFA/CA) n=16 participants at risk Tremelimumab (trem) 75mg flat dose every (q)28 days for 4 doses and Durvalumab (dur) 1500mg flat dose q28 days until end of study. 30 total (e.g. Per the study design, this is the number of participants we planned to treat): 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem + dur + cryoablation
Gastrointestinal disorders Abdominal distension	11.1% 4/36 • Number of events 7 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Abdominal pain	44.4% 16/36 • Number of events 24 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	43.8% 7/16 • Number of events 14 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Acidosis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Activated partial thromboplastin time prolonged	47.2% 17/36 • Number of events 32 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	43.8% 7/16 • Number of events 24 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Renal and urinary disorders Acute kidney injury	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Alanine aminotransferase increased	66.7% 24/36 • Number of events 65 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	81.2% 13/16 • Number of events 50 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Alkaline phosphatase increased	72.2% 26/36 • Number of events 96 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	81.2% 13/16 • Number of events 42 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Immune system disorders Allergic reaction	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.8% 1/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Blood and lymphatic system disorders Anemia	88.9% 32/36 • Number of events 181 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	93.8% 15/16 • Number of events 55 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Anorexia	19.4% 7/36 • Number of events 7 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 6 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 2/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Arthritis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Ascites	11.1% 4/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Aspartate aminotransferase increased	86.1% 31/36 • Number of events 128 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	81.2% 13/16 • Number of events 52 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Immune system disorders Autoimmune disorder	5.6% 2/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Back pain	16.7% 6/36 • Number of events 6 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 6 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Bloating	30.6% 11/36 • Number of events 14 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, aPTT decreased	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Blood bilirubin increased	38.9% 14/36 • Number of events 60 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	56.2% 9/16 • Number of events 25 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Eye disorders Blurred vision	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Bone pain	8.3% 3/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Injury, poisoning and procedural complications Bruising	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Bullous dermatitis	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations CPK increased	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Eye disorders Cataract	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Catheter related infection	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Chest wall pain	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Chills	11.1% 4/36 • Number of events 5 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Colitis	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Psychiatric disorders Confusion	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Constipation	50.0% 18/36 • Number of events 29 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 10 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Cough	22.2% 8/36 • Number of events 8 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Creatinine increased	44.4% 16/36 • Number of events 76 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 11 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Dehydration	13.9% 5/36 • Number of events 6 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Psychiatric disorders Delirium	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Depressed level of consciousness	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Psychiatric disorders Depression	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Diarrhea	25.0% 9/36 • Number of events 10 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 5 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Dizziness	11.1% 4/36 • Number of events 6 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Eye disorders Dry eye	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Dry mouth	22.2% 8/36 • Number of events 9 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Dry skin	19.4% 7/36 • Number of events 10 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Dyspepsia	11.1% 4/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Dysphagia	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Dyspnea	19.4% 7/36 • Number of events 9 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 13 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Edema limbs	27.8% 10/36 • Number of events 15 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	25.0% 4/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Reproductive system and breast disorders Erectile dysfunction	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Erythema multiforme	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Esophageal varices hemorrhage	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Eye disorders Eye disorders - Other, Eye irritation	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Eye disorders Eye disorders - Other, Eye itching	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Facial nerve disorder	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Injury, poisoning and procedural complications Fall	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Fatigue	58.3% 21/36 • Number of events 36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	75.0% 12/16 • Number of events 21 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Fever	30.6% 11/36 • Number of events 13 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	56.2% 9/16 • Number of events 19 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Fibrinogen decreased	8.3% 3/36 • Number of events 6 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Flank pain	5.6% 2/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Injury, poisoning and procedural complications Fracture	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Gastroesophageal reflux disease	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Gastrointestinal disorders - Other, Abdominal discomfort	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Gastrointestinal disorders - Other, Abdominal fullness	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Gastrointestinal disorders - Other, Bloating	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Gastrointestinal disorders - Other, Epigastric pain	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Gastrointestinal disorders - Other, Indigestion	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Gastroparesis	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders General disorders and administration site conditions - Other, Chest soreness	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders General disorders and administration site conditions - Other, Muscle spasm	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders General disorders and administration site conditions - Other, Numbness - left hand	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	13.9% 5/36 • Number of events 5 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Eye disorders Glaucoma	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Headache	19.4% 7/36 • Number of events 10 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Vascular disorders Hematoma	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Renal and urinary disorders Hematuria	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Hemorrhoids	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Hepatic infection	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Vascular disorders Hot flashes	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypercalcemia	30.6% 11/36 • Number of events 18 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	43.8% 7/16 • Number of events 15 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hyperglycemia	36.1% 13/36 • Number of events 47 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	31.2% 5/16 • Number of events 8 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hyperkalemia	22.2% 8/36 • Number of events 14 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypermagnesemia	25.0% 9/36 • Number of events 18 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypernatremia	16.7% 6/36 • Number of events 17 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Vascular disorders Hypertension	8.3% 3/36 • Number of events 5 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Endocrine disorders Hyperthyroidism	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hyperuricemia	19.4% 7/36 • Number of events 43 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 9 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypoalbuminemia	77.8% 28/36 • Number of events 132 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	68.8% 11/16 • Number of events 26 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypocalcemia	13.9% 5/36 • Number of events 9 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypoglycemia	5.6% 2/36 • Number of events 15 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypokalemia	30.6% 11/36 • Number of events 32 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypomagnesemia	19.4% 7/36 • Number of events 20 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	31.2% 5/16 • Number of events 6 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hyponatremia	83.3% 30/36 • Number of events 103 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	75.0% 12/16 • Number of events 25 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Metabolism and nutrition disorders Hypophosphatemia	52.8% 19/36 • Number of events 53 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 12 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Vascular disorders Hypotension	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Endocrine disorders Hypothyroidism	8.3% 3/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations INR increased	5.6% 2/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Immune system disorders Immune system disorders - Other, Allergy development	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Immune system disorders Immune system disorders - Other, Skin rash near anus/groin	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Infections and infestations - Other, Headaches and nose bleeds	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Infections and infestations - Other, Staph	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Infections and infestations - Other, Thrush	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Infections and infestations - Other, Tinea cruris	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Infections and infestations - Other, cold sore	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Psychiatric disorders Insomnia	22.2% 8/36 • Number of events 8 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	25.0% 4/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Investigations - Other, Elevated TSH	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Lethargy	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Lipase increased	11.1% 4/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Localized edema	2.8% 1/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Lymphocyte count decreased	97.2% 35/36 • Number of events 243 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	81.2% 13/16 • Number of events 47 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Malaise	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Memory impairment	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Mucositis oral	8.3% 3/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Cramping - calves	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Leg cramps	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Myalgia	2.8% 1/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Myositis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Nausea	41.7% 15/36 • Number of events 18 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	50.0% 8/16 • Number of events 11 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Nervous system disorders - Other, Tongue numbness	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Neutrophil count decreased	16.7% 6/36 • Number of events 35 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Non-cardiac chest pain	8.3% 3/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
General disorders Pain	55.6% 20/36 • Number of events 36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	43.8% 7/16 • Number of events 9 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 4/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Papulopustular rash	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Paresthesia	8.3% 3/36 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Reproductive system and breast disorders Pelvic pain	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Peripheral sensory neuropathy	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Platelet count decreased	69.4% 25/36 • Number of events 82 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 9 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Pruritus	36.1% 13/36 • Number of events 17 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	43.8% 7/16 • Number of events 8 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Rash acneiform	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Rash maculo-papular	41.7% 15/36 • Number of events 24 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 8 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Respiratory failure	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Pneumonia	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Pulmonary abnormalities	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, SOB	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Sepsis	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Serum amylase increased	58.3% 21/36 • Number of events 130 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 7 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Cardiac disorders Sinus bradycardia	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Cardiac disorders Sinus tachycardia	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Abrasion on forehead	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Brown lesion/rash	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Cracked skin	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Dermatitis - penis	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Dermatitis - right buttocks	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Face swelling	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Itching	11.1% 4/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Itching arm and chest	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Itchy back	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Keratosis; frontal scalp	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Mild rash on shoulder and sparsely on back	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Night sweats	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Plaque rash	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Psoriasis; lower back	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Redness to radiation area	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Skin discoloration	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Swelling - left leg	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Swollen feet and ankles	0.00% 0/36 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Wound to gluteal folds	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, itching-anus	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, swelling- ankle	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, swelling- feet/legs	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	11.1% 4/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Skin and subcutaneous tissue disorders Skin hypopigmentation	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Skin infection	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Somnolence	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Sore throat	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Nervous system disorders Stroke	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Upper respiratory infection	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Renal and urinary disorders Urinary frequency	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Renal and urinary disorders Urinary incontinence	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Renal and urinary disorders Urinary retention	11.1% 4/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Infections and infestations Urinary tract infection	5.6% 2/36 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Gastrointestinal disorders Vomiting	27.8% 10/36 • Number of events 13 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	37.5% 6/16 • Number of events 7 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Eye disorders Watering eyes	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations Weight loss	11.1% 4/36 • Number of events 4 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	12.5% 2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Respiratory, thoracic and mediastinal disorders Wheezing	2.8% 1/36 • Number of events 1 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	0.00% 0/16 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.
Investigations White blood cell decreased	52.8% 19/36 • Number of events 100 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.	18.8% 3/16 • Number of events 7 • Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.

Additional Information

Dr. Tim F. Greten

Principal Investigator

Phone: 240-760-6114

Email: tim.greten@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place