Trial Outcomes & Findings for FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (NCT NCT01721954)

NCT ID: NCT01721954

Last Updated: 2019-11-05

Results Overview

OS defined as the time interval between the date of randomization and the date of death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

209 participants

Primary outcome timeframe

From date of randomization until the date of death from any cause assessed up 3 yrs 8 months

Results posted on

2019-11-05

Participant Flow

Between 01May2013\&24Dec2014,209 patients were screened\&randomised from 87centres in Australia, Belgium,France, Germany, Israel, Italy, Korea, New Zealand, Portugal, Singapore, Spain,Taiwan \&the US. 209 patients randomized in the Intent to treat (ITT) population. 5 patients who did not receive study medication were not included in safety population.

Participant milestones

Participant milestones
Measure	mFOLFOX6 Plus SIRT Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	mFOLFOX6 Alone Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Overall Study STARTED	105	104
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	70	69

Reasons for withdrawal

Reasons for withdrawal
Measure	mFOLFOX6 Plus SIRT Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	mFOLFOX6 Alone Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Overall Study Death	58	64
Overall Study Withdrawal by Subject	8	4
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mFOLFOX6 Plus SIRT n=105 Participants Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	mFOLFOX6 Alone n=104 Participants Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m	Total n=209 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 11.28 • n=5 Participants	62.4 years STANDARD_DEVIATION 10.06 • n=7 Participants	62.5 years STANDARD_DEVIATION 10.66 • n=5 Participants
Age, Customized Age, Categorical · Below 65 years	60 Participants n=5 Participants	57 Participants n=7 Participants	117 Participants n=5 Participants
Age, Customized Age, Categorical · Greater than or equal to 65 years	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	44 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	60 Participants n=7 Participants	124 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 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
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	93 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
WHO performance status 0	61 Participants n=5 Participants	53 Participants n=7 Participants	114 Participants n=5 Participants
WHO performance status 1	44 Participants n=5 Participants	50 Participants n=7 Participants	94 Participants n=5 Participants
WHO performance status Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Extra-hepatic Disease Yes	32 participants n=5 Participants	27 participants n=7 Participants	59 participants n=5 Participants
Extra-hepatic Disease No	73 participants n=5 Participants	77 participants n=7 Participants	150 participants n=5 Participants
Liver Involvement % <=25%	74 participants n=5 Participants	74 participants n=7 Participants	148 participants n=5 Participants
Liver Involvement % >25%	31 participants n=5 Participants	30 participants n=7 Participants	61 participants n=5 Participants
Tumor volume	18.5 percentage of liver STANDARD_DEVIATION 17.77 • n=5 Participants	17.9 percentage of liver STANDARD_DEVIATION 16.18 • n=7 Participants	18.2 percentage of liver STANDARD_DEVIATION 16.96 • n=5 Participants
ITT bevacizumab Yes	87 Participants n=5 Participants	87 Participants n=7 Participants	174 Participants n=5 Participants
ITT bevacizumab No	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months

Population: ITT population

OS defined as the time interval between the date of randomization and the date of death from any cause.

Outcome measures

Outcome measures
Measure	mFOLFOX6 Plus SIRT n=105 Participants Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	mFOLFOX6 Alone n=104 Participants Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Overall Survival (OS)	25.9 months Interval 23.1 to 29.0	25.0 months Interval 22.1 to 28.5

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.

Population: ITT population

PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.

Outcome measures

Outcome measures
Measure	mFOLFOX6 Plus SIRT n=105 Participants Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	mFOLFOX6 Alone n=104 Participants Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Progression-free Survival	11.8 months Interval 10.3 to 14.5	11.2 months Interval 9.4 to 12.6

Adverse Events

mFOLFOX6 Plus SIRT

Serious events: 47 serious events

Other events: 92 other events

Deaths: 58 deaths

mFOLFOX6 Alone

Serious events: 47 serious events

Other events: 111 other events

Deaths: 64 deaths

Serious adverse events

Other adverse events

Additional Information

Janet Bell, M.B.A.

Sirtex Medical

Phone: + 888-474-7839

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	mFOLFOX6 Plus SIRT n=92 participants at risk Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	mFOLFOX6 Alone n=112 participants at risk Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Blood and lymphatic system disorders Febrile Neutropenia	10.9% 10/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	2.7% 3/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Blood and lymphatic system disorders Neutropenia	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Blood and lymphatic system disorders Pancytopenia	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Cardiac disorders Acute Myocardial Infarction	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Cardiac disorders Arteriospasm Coronary	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Cardiac disorders Cardiac Failure	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Cardiac disorders Cardiotoxicity	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Eye disorders Retinal Detachment	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Eye disorders Vitreous Haemorrhage	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Abdominal Pain	9.8% 9/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Anal Fissure	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Colitis	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Diarrhoea	5.4% 5/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	4.5% 5/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Duodenal Perforation	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Enterocolitis	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Gastric Ulcer	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Gastritis	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Gastrointestinal Haemorrhage	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Haematemesis	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Intestinal Obstruction	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	1.8% 2/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Large Intestinal Obstruction	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Large Intestine Perforation	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Nausea	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Neutropenic Colitis	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Pancreatitis	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Varices Oesophageal	0.00% 0/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Vomiting	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Asthenia	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Chest Pain	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Fatigue	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders General Physical Health Deterioration	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	1.8% 2/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Malaise	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Mucosal Inflammation	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Pain	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Pyrexia	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	2.7% 3/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Hepatobiliary disorders Cholelithiasis	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.00% 0/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.

Other adverse events
Measure	mFOLFOX6 Plus SIRT n=92 participants at risk Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres. FOLFOX6m SIR-Spheres microspheres	mFOLFOX6 Alone n=112 participants at risk Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. FOLFOX6m
Blood and lymphatic system disorders Neutropenia	46.7% 43/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	41.1% 46/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Blood and lymphatic system disorders Thrombocytopenia	42.4% 39/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	9.8% 11/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Blood and lymphatic system disorders Anaemia	22.8% 21/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	13.4% 15/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Blood and lymphatic system disorders Leukopenia	14.1% 13/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	8.9% 10/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Blood and lymphatic system disorders Lymphopenia	6.5% 6/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Eye disorders Lacrimation Increased	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	5.4% 6/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Nausea	50.0% 46/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	49.1% 55/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Diarrhoea	38.0% 35/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	52.7% 59/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Constipation	42.4% 39/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	40.2% 45/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Abdominal Pain	35.9% 33/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	21.4% 24/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Vomiting	26.1% 24/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	29.5% 33/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Stomatitis	22.8% 21/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	25.9% 29/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Abdominal Pain Upper	21.7% 20/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	10.7% 12/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	7.6% 7/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	12.5% 14/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Mouth Ulceration	4.3% 4/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	12.5% 14/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Abdominal Distension	9.8% 9/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	6.2% 7/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Rectal Haemorrhage	7.6% 7/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	6.2% 7/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Dry Mouth	3.3% 3/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	8.0% 9/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Ascites	9.8% 9/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Dyspepsia	5.4% 5/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	4.5% 5/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Gastrointestinal disorders Gastritis	5.4% 5/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	0.89% 1/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Fatigue	52.2% 48/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	43.8% 49/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Mucosal Inflammation	13.0% 12/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	20.5% 23/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Asthenia	16.3% 15/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	16.1% 18/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Pyrexia	18.5% 17/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	14.3% 16/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Oedema Peripheral	14.1% 13/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	5.4% 6/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Pain	3.3% 3/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	7.1% 8/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
General disorders Chest Pain	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	7.1% 8/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Infections and infestations Urinary Tract Infection	9.8% 9/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	8.9% 10/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Infections and infestations Upper Respiratory Tract Infection	10.9% 10/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	7.1% 8/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Infections and infestations Nasopharyngitis	2.2% 2/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	7.1% 8/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Infections and infestations Bronchitis	1.1% 1/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	5.4% 6/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Injury, poisoning and procedural complications Contusion	5.4% 5/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	2.7% 3/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Injury, poisoning and procedural complications Fall	5.4% 5/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	1.8% 2/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Investigations Weight Decreased	31.5% 29/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	17.0% 19/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Investigations Neutrophil Count Decreased	7.6% 7/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	7.1% 8/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Investigations Weight Increased	5.4% 5/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	8.0% 9/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Investigations Platelet Count Decreased	9.8% 9/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	3.6% 4/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Investigations Aspartate Aminotransferase Increased	9.8% 9/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	1.8% 2/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.
Investigations Blood Alkaline Phosphatase Increased	6.5% 6/92 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.	4.5% 5/112 • From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants. The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.