Trial Outcomes & Findings for FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer (NCT NCT00724503)

Last Updated: 2019-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

530 participants

Primary 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 60 months

Results posted on

2019-03-26

Participant Flow

Between 10 October 2006 and 26 April 2013, 561 patients were screened. 31 screen failures included 2 patients who were randomized twice. 530 patients were randomized in the Intent to treat (ITT) population from 87 centres in Australia, Europe including Belgium, France, Germany, Israel, Italy and Spain, New Zealand and the US.

Participant milestones

Participant milestones
Measure	mFOLFOX6 Plus SIRT A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	mFOLFOX6 Alone systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Overall Study STARTED	267	263
Overall Study COMPLETED	57	43
Overall Study NOT COMPLETED	210	220

Reasons for withdrawal

Reasons for withdrawal
Measure	mFOLFOX6 Plus SIRT A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	mFOLFOX6 Alone systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Overall Study Lost to Follow-up	4	8
Overall Study Withdrawal by Subject	11	23
Overall Study Death	190	182
Overall Study Adverse Event	1	0
Overall Study Not otherwise specified	4	7

Baseline Characteristics

Age was unknown for 1 patient as patient withdrew consent and records

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mFOLFOX6 Plus SIRT n=267 Participants A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	mFOLFOX6 Alone n=263 Participants Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	Total n=530 Participants Total of all reporting groups
Age, Continuous	63 years n=267 Participants • Age was unknown for 1 patient as patient withdrew consent and records	63 years n=262 Participants • Age was unknown for 1 patient as patient withdrew consent and records	63 years n=529 Participants • Age was unknown for 1 patient as patient withdrew consent and records
Sex: Female, Male Female	85 Participants n=267 Participants • Sex was unknown for 1 patient as patient withdrew consent and records	88 Participants n=262 Participants • Sex was unknown for 1 patient as patient withdrew consent and records	173 Participants n=529 Participants • Sex was unknown for 1 patient as patient withdrew consent and records
Sex: Female, Male Male	182 Participants n=267 Participants • Sex was unknown for 1 patient as patient withdrew consent and records	174 Participants n=262 Participants • Sex was unknown for 1 patient as patient withdrew consent and records	356 Participants n=529 Participants • Sex was unknown for 1 patient as patient withdrew consent and records
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=267 Participants	0 Participants n=263 Participants	0 Participants n=530 Participants
Race (NIH/OMB) Asian	7 Participants n=267 Participants	3 Participants n=263 Participants	10 Participants n=530 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=267 Participants	0 Participants n=263 Participants	0 Participants n=530 Participants
Race (NIH/OMB) Black or African American	2 Participants n=267 Participants	8 Participants n=263 Participants	10 Participants n=530 Participants
Race (NIH/OMB) White	248 Participants n=267 Participants	243 Participants n=263 Participants	491 Participants n=530 Participants
Race (NIH/OMB) More than one race	4 Participants n=267 Participants	4 Participants n=263 Participants	8 Participants n=530 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=267 Participants	5 Participants n=263 Participants	11 Participants n=530 Participants
WHO performance status 0	176 participants n=267 Participants	175 participants n=263 Participants	351 participants n=530 Participants
WHO performance status 1	90 participants n=267 Participants	87 participants n=263 Participants	177 participants n=530 Participants
WHO performance status Unknown	1 participants n=267 Participants	1 participants n=263 Participants	2 participants n=530 Participants
Primary tumor in situ No	148 Participants n=267 Participants	141 Participants n=263 Participants	289 Participants n=530 Participants
Primary tumor in situ Yes	119 Participants n=267 Participants	121 Participants n=263 Participants	240 Participants n=530 Participants
Primary tumor in situ Unknown	0 Participants n=267 Participants	1 Participants n=263 Participants	1 Participants n=530 Participants
Extra-hepatic metastases at randomization No	160 participants n=267 Participants	159 participants n=263 Participants	319 participants n=530 Participants
Extra-hepatic metastases at randomization Yes	107 participants n=267 Participants	104 participants n=263 Participants	211 participants n=530 Participants
Tumor liver involvement % <=25%	185 Participants n=267 Participants	192 Participants n=263 Participants	377 Participants n=530 Participants
Tumor liver involvement % >25%	81 Participants n=267 Participants	70 Participants n=263 Participants	151 Participants n=530 Participants
Tumor liver involvement % Unknown	1 Participants n=267 Participants	1 Participants n=263 Participants	2 Participants n=530 Participants
Synchronous metastases	241 Participants n=267 Participants	233 Participants n=263 Participants	474 Participants n=530 Participants

PRIMARY 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 60 months

Population: ITT population

Outcome measures

Outcome measures
Measure	mFOLFOX6 Plus SIRT n=267 Participants A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	mFOLFOX6 Alone n=263 Participants Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Progression-Free Survival (PFS) at Any Site	10.7 Months Interval 9.9 to 11.4	10.2 Months Interval 9.4 to 11.3

SECONDARY outcome

Timeframe: Through study completion, up to 60 months

Tumour Response Rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR) - Disappearance of all target lesions which is confirmed if determined by two observations not less than 4 weeks apart; Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	mFOLFOX6 Plus SIRT n=267 Participants A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	mFOLFOX6 Alone n=263 Participants Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Percentage of Participants With Overall Response	76.4 percentage of participants	68.1 percentage of participants

Adverse Events

mFOLFOX6 Plus SIRT

Serious events: 134 serious events

Other events: 112 other events

Deaths: 190 deaths

mFOLFOX6 Alone

Serious events: 112 serious events

Other events: 157 other events

Deaths: 182 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=246 participants at risk A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	mFOLFOX6 Alone n=270 participants at risk systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Injury, poisoning and procedural complications Fall	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.74% 2/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Injury, poisoning and procedural complications Contrast Media Reaction	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Anaemia	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	1.5% 4/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Febrile Neutropenia	5.3% 13/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	1.5% 4/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Heparin-Induced Thrombocytopenia	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Neutropenia	1.2% 3/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.74% 2/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Splenic Infarction	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Thrombocytopenia	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Acute Coronary Syndrome	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Acute Myocardial Infarction	0.81% 2/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.74% 2/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Angina Pectoris	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Arrhythmia	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Arteriospasm Coronary	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Atrial Fibrillation	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Atrial Flutter	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Atrioventricular Block Complete	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Cardiac Arrest	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Cardiac Failure	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Intracardiac Thrombus	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Myocardial Infarction	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Stress Cardiomyopathy	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Congenital, familial and genetic disorders Hydrocele	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Ear and labyrinth disorders Vertigo	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Abdominal Pain	4.5% 11/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	1.9% 5/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Abdominal Pain Upper	1.6% 4/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Anal Fissure	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.74% 2/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Anal Inflammation	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Ascites	1.6% 4/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Constipation	4.1% 10/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	2.6% 7/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Diarrhoea	4.5% 11/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	3.0% 8/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Duodenal Ulcer	1.2% 3/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Duodenitis	0.81% 2/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Erosive Oesophagitis	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Gastric Haemorrhage	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Gastric Ulcer	2.4% 6/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Gastritis	1.6% 4/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Gastritis Atrophic	0.41% 1/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.00% 0/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Gastritis Erosive	0.00% 0/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	0.37% 1/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.

Other adverse events
Measure	mFOLFOX6 Plus SIRT n=246 participants at risk A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	mFOLFOX6 Alone n=270 participants at risk systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
Blood and lymphatic system disorders Anaemia	11.8% 29/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	14.1% 38/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Febrile Neutropenia	6.1% 15/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	1.9% 5/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Leukopenia	13.4% 33/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	7.8% 21/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Lymphopenia	6.1% 15/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	1.9% 5/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Neutropenia	26.8% 66/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	37.8% 102/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Blood and lymphatic system disorders Thrombocytopenia	39.4% 97/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	17.4% 47/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Abdominal Pain	41.9% 103/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	19.6% 53/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Abdominal Pain Upper	31.3% 77/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	8.1% 22/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Ascites	9.3% 23/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	1.5% 4/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Constipation	43.9% 108/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	33.7% 91/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Diarrhoea	41.9% 103/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	48.9% 132/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Dyspepsia	10.2% 25/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	8.1% 22/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	7.3% 18/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	9.3% 25/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Nausea	6.1% 15/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	50.7% 137/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Rectal Haemorrhage	9.3% 23/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	6.7% 18/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Stomatitis	18.3% 45/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	17.4% 47/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Gastrointestinal disorders Vomiting	38.6% 95/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	27.4% 74/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
General disorders Asthenia	15.9% 39/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	10.0% 27/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
General disorders Chest Pain	9.3% 23/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	3.7% 10/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
General disorders Fatigue	10.6% 26/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	49.6% 134/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
General disorders Mucosal Inflammation	16.3% 40/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	20.0% 54/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
General disorders Oedema Peripheral	14.2% 35/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	6.3% 17/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
General disorders Pyrexia	23.2% 57/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	15.9% 43/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Immune system disorders Drug Hypersensitivity	5.3% 13/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	2.6% 7/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Infections and infestations Upper Respiratory Tract Infection	6.1% 15/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	8.9% 24/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Infections and infestations Urinary Tract Infection	7.7% 19/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	5.6% 15/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Injury, poisoning and procedural complications Procedural Pain	13.0% 32/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	1.5% 4/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Investigations Aspartate Aminotransferase Increased	5.3% 13/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	2.6% 7/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Injury, poisoning and procedural complications Blood Alkaline Phosphatase Increased	5.3% 13/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	3.0% 8/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Investigations Neutrophil Count Decreased	10.2% 25/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	4.4% 12/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Investigations Platelet Count Decreased	10.2% 25/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	3.7% 10/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Investigations Weight Decreased	22.4% 55/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	14.4% 39/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Investigations Weight Increased	6.1% 15/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	7.8% 21/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Investigations White Blood Cell Count Decreased	6.1% 15/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	1.5% 4/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Metabolism and nutrition disorders Decreased Appetite	31.3% 77/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	28.5% 77/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Metabolism and nutrition disorders Dehydration	5.7% 14/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	4.4% 12/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Metabolism and nutrition disorders Hyperglycaemia	4.1% 10/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	5.9% 16/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Metabolism and nutrition disorders Hypokalaemia	9.3% 23/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	5.6% 15/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 16/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	4.4% 12/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Musculoskeletal and connective tissue disorders Back Pain	13.0% 32/246 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.	8.1% 22/270 • From consent until 28 days post last dose of protocol chemotherapy. Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment. Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants. The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.