Trial Outcomes & Findings for Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer (NCT NCT01483027)

NCT ID: NCT01483027

Last Updated: 2022-03-29

Results Overview

Progression Free survival by blinded independent central review per RECIST 1.1

Recruitment status

COMPLETED

Study phase

Target enrollment

428 participants

Primary outcome timeframe

From date of randomization until the date of first documented progression, as defined by RECIST 1:1 or date of death from any cause, whichever comes first, assessed up to a minimum of 1 year follow up or until study completion

Results posted on

2022-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group Standard of care second-line chemotherapy plus TheraSphere TheraSphere: yttrium 90 microspheres	Control Group Standard of care second-line chemotherapy with no added therapy
Overall Study STARTED	215	213
Overall Study COMPLETED	169	153
Overall Study NOT COMPLETED	46	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group Standard of care second-line chemotherapy plus TheraSphere TheraSphere: yttrium 90 microspheres	Control Group Standard of care second-line chemotherapy with no added therapy
Overall Study Administrative Reasons	2	1
Overall Study Withdrawal by Subject	0	1
Overall Study Discontinuation by Investigator or Sponsor for any reason	22	24
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Three patients without baseline ECOG status are excluded from this analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=215 Participants Standard of care second-line chemotherapy plus TheraSphere TheraSphere: yttrium 90 microspheres	Control Group n=213 Participants Standard of care second-line chemotherapy with no added therapy	Total n=428 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=215 Participants	0 Participants n=213 Participants	0 Participants n=428 Participants
Age, Categorical Between 18 and 65 years	126 Participants n=215 Participants	132 Participants n=213 Participants	258 Participants n=428 Participants
Age, Categorical >=65 years	89 Participants n=215 Participants	81 Participants n=213 Participants	170 Participants n=428 Participants
Sex: Female, Male Female	80 Participants n=215 Participants	75 Participants n=213 Participants	155 Participants n=428 Participants
Sex: Female, Male Male	135 Participants n=215 Participants	138 Participants n=213 Participants	273 Participants n=428 Participants
Race/Ethnicity, Customized White or Caucasian	164 Participants n=215 Participants	169 Participants n=213 Participants	333 Participants n=428 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=215 Participants	8 Participants n=213 Participants	17 Participants n=428 Participants
Race/Ethnicity, Customized Asian	25 Participants n=215 Participants	17 Participants n=213 Participants	42 Participants n=428 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=215 Participants	0 Participants n=213 Participants	1 Participants n=428 Participants
Race/Ethnicity, Customized Other	1 Participants n=215 Participants	1 Participants n=213 Participants	2 Participants n=428 Participants
Race/Ethnicity, Customized Missing	15 Participants n=215 Participants	18 Participants n=213 Participants	33 Participants n=428 Participants
Region of Enrollment Singapore	5 participants n=215 Participants	2 participants n=213 Participants	7 participants n=428 Participants
Region of Enrollment United States	54 participants n=215 Participants	50 participants n=213 Participants	104 participants n=428 Participants
Region of Enrollment United Kingdom	52 participants n=215 Participants	75 participants n=213 Participants	127 participants n=428 Participants
Region of Enrollment Spain	22 participants n=215 Participants	17 participants n=213 Participants	39 participants n=428 Participants
Region of Enrollment Canada	9 participants n=215 Participants	6 participants n=213 Participants	15 participants n=428 Participants
Region of Enrollment Austria	0 participants n=215 Participants	2 participants n=213 Participants	2 participants n=428 Participants
Region of Enrollment South Korea	13 participants n=215 Participants	9 participants n=213 Participants	22 participants n=428 Participants
Region of Enrollment Belgium	4 participants n=215 Participants	0 participants n=213 Participants	4 participants n=428 Participants
Region of Enrollment Hong Kong	3 participants n=215 Participants	1 participants n=213 Participants	4 participants n=428 Participants
Region of Enrollment Poland	28 participants n=215 Participants	28 participants n=213 Participants	56 participants n=428 Participants
Region of Enrollment France	15 participants n=215 Participants	18 participants n=213 Participants	33 participants n=428 Participants
Region of Enrollment Germany	10 participants n=215 Participants	5 participants n=213 Participants	15 participants n=428 Participants
Baseline Characteristics ECOG 0 at baseline	119 Participants n=214 Participants • Three patients without baseline ECOG status are excluded from this analysis	133 Participants n=211 Participants • Three patients without baseline ECOG status are excluded from this analysis	252 Participants n=425 Participants • Three patients without baseline ECOG status are excluded from this analysis
Baseline Characteristics ECOG 1 at baseline	95 Participants n=214 Participants • Three patients without baseline ECOG status are excluded from this analysis	78 Participants n=211 Participants • Three patients without baseline ECOG status are excluded from this analysis	173 Participants n=425 Participants • Three patients without baseline ECOG status are excluded from this analysis
KRAS status KRAS mutant	100 Participants n=215 Participants	101 Participants n=213 Participants	201 Participants n=428 Participants
KRAS status KRAS wildtype	115 Participants n=215 Participants	112 Participants n=213 Participants	227 Participants n=428 Participants
Unilobar vs Bilobar disease at baseline unilobar	39 Participants n=215 Participants	40 Participants n=213 Participants	79 Participants n=428 Participants
Unilobar vs Bilobar disease at baseline bilobar	176 Participants n=215 Participants	173 Participants n=213 Participants	349 Participants n=428 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression, as defined by RECIST 1:1 or date of death from any cause, whichever comes first, assessed up to a minimum of 1 year follow up or until study completion

Population: Outcome measurement includes data from all subjects in the ITT.

Progression Free survival by blinded independent central review per RECIST 1.1

Outcome measures

Outcome measures
Measure	Treatment Group n=215 Participants Standard of care second-line chemotherapy plus TheraSphere TheraSphere: yttrium 90 microspheres	Control Group n=213 Participants Standard of care second-line chemotherapy with no added therapy
Progression Free Survival	8.0 Months Interval 7.2 to 9.2	7.2 Months Interval 5.7 to 7.6

PRIMARY outcome

Timeframe: Time from randomization until hepatic PD by BICR per RECIST 1.1 or death, whichever occurs first, assessed up to a minimum of 1 year follow up or study completion.

Population: Outcome measurement includes data from all subjects in the ITT.

Hepatic Progression Free Survival (HPFS) by blinded independant central review per RECIST 1.1

Outcome measures

Outcome measures
Measure	Treatment Group n=215 Participants Standard of care second-line chemotherapy plus TheraSphere TheraSphere: yttrium 90 microspheres	Control Group n=213 Participants Standard of care second-line chemotherapy with no added therapy
Hepatic Progression-Free Survival (HPFS)	9.1 Months Interval 7.8 to 9.7	7.2 Months Interval 5.7 to 7.6

SECONDARY outcome

Timeframe: Time from date of randomization until date of death due to any cause; patients remaining on study post progression were followed until study completion; duration of follow up could be a few months to several years depending on when event was met.

Population: ITT: all randomized patients with patient analyzed according to the treatment group to which they were randomized

Time from randomization until date of death due to any cause as reported by study site.

Outcome measures

Outcome measures
Measure	Treatment Group n=215 Participants Standard of care second-line chemotherapy plus TheraSphere TheraSphere: yttrium 90 microspheres	Control Group n=213 Participants Standard of care second-line chemotherapy with no added therapy
Overall Survival	14 Months Interval 11.8 to 15.5	14.4 Months Interval 12.8 to 16.4

Adverse Events

Treatment Group

Serious events: 95 serious events

Other events: 186 other events

Deaths: 182 deaths

Control Group

Serious events: 47 serious events

Other events: 196 other events

Deaths: 165 deaths

Serious adverse events

Other adverse events

Additional Information

Chantal Laframboise

Boston Scientific

Phone: +1 613 882 0876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Treatment Group n=187 participants at risk Standard of care second-line chemotherapy plus TheraSphere TheraSphere: yttrium 90 microspheres	Control Group n=207 participants at risk Standard of care second-line chemotherapy with no added therapy
Blood and lymphatic system disorders Febrile Neutropenia	4.3% 8/187 • Number of events 9 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	1.4% 3/207 • Number of events 3 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Neutropenia	2.1% 4/187 • Number of events 8 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	1.4% 3/207 • Number of events 5 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Anemia	1.6% 3/187 • Number of events 3 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Thrombocytopenia	1.6% 3/187 • Number of events 4 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Pancytopenia	0.53% 1/187 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Splenic infarction	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Acute myocardial infarction	1.1% 2/187 • Number of events 4 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Atrial fibrillation	1.1% 2/187 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Angina pectoris	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Arteriospasm coronary	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Cardiac failure	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Cardiac failure chronic	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Cardiomyopathy	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Myocardial infarction	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Pericardial effusion	0.00% 0/187 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Sinus tachycardia	0.00% 0/187 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Ear and labyrinth disorders Vertigo	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Abdominal pain	5.3% 10/187 • Number of events 11 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	1.9% 4/207 • Number of events 4 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Ascites	5.9% 11/187 • Number of events 15 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Diarrhoea	2.1% 4/187 • Number of events 4 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	2.4% 5/207 • Number of events 5 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Vomiting	2.1% 4/187 • Number of events 4 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Colonic obstruction	2.1% 4/187 • Number of events 4 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Intestinal obstruction	1.6% 3/187 • Number of events 3 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Small intestinal obstruction	1.1% 2/187 • Number of events 3 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Constipation	1.1% 2/187 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Nausea	1.1% 2/187 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Abdominal distension	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Abdominal pain upper	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Colitis	0.00% 0/187 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Duodenal perforation	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Duodenal ulcer	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Gastric perforation	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Gastric ulcer	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Gastritis	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Intestinal haemorrhage	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Gastrointestinal disorders Intestinal ischaemia	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).

Other adverse events
Measure	Treatment Group n=187 participants at risk Standard of care second-line chemotherapy plus TheraSphere TheraSphere: yttrium 90 microspheres	Control Group n=207 participants at risk Standard of care second-line chemotherapy with no added therapy
Blood and lymphatic system disorders Neutropenia	34.2% 64/187 • Number of events 172 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	24.2% 50/207 • Number of events 99 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Thrombocytopenia	20.3% 38/187 • Number of events 89 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	9.2% 19/207 • Number of events 37 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Anaemia	13.9% 26/187 • Number of events 39 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	5.3% 11/207 • Number of events 16 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Leukopenia	10.2% 19/187 • Number of events 29 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	2.9% 6/207 • Number of events 6 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Febrile neutropenia	4.3% 8/187 • Number of events 9 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	1.4% 3/207 • Number of events 3 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Lymphopenia	4.3% 8/187 • Number of events 12 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Leukocytosis	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	1.9% 4/207 • Number of events 7 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Pancytopenia	0.53% 1/187 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.97% 2/207 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Bone marrow failure	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Granulocytopenia	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Splenomegaly	1.1% 2/187 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Splenic infarction	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders Thrombocytopenic purpura	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Blood and lymphatic system disorders White blood cell disorder	0.00% 0/187 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Angina pectoris	2.1% 4/187 • Number of events 7 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Sinus tachycardia	1.6% 3/187 • Number of events 3 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Tachycardia	2.1% 4/187 • Number of events 4 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Acute myocardial infarction	1.1% 2/187 • Number of events 4 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Arrhythmia	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Atrial fibrillation	1.1% 2/187 • Number of events 3 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Cardiac disorders	1.1% 2/187 • Number of events 2 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Myocardial infarction	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Arteriospasm coronary	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Artial thrombosis	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Bradycardia	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Cardiac failure chronic	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Cardiomyopathy	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Coronary artery disease	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Cyanosis	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Palpitations	0.00% 0/187 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Cardiac disorders Pericardial effusion	0.00% 0/187 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Ear and labyrinth disorders Vertigo	2.1% 4/187 • Number of events 5 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	1.9% 4/207 • Number of events 5 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Ear and labyrinth disorders Deafness	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/187 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.48% 1/207 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Ear and labyrinth disorders Ear pain	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Ear and labyrinth disorders Hearing impaired	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Ear and labyrinth disorders Hypoacusis	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Endocrine disorders Hypothyroidism	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.53% 1/187 • Number of events 1 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).	0.00% 0/207 • AEs and SAEs were collected until progression of disease or 30 days following discontinuation date of study therapy (chemo or TheraSphere), whichever comes first, on average up to 6 months depending on number of chemo cycles. After this only AEs, SAEs related to TheraSphere were collected through study completion, on average up to one year post treatment. All-cause mortality was collected through study completion, on average up to two years after first study treatment. Adverse events presented here are based on the Safety Population: all randomized patients who received at least 1 administration of TheraSphere or chemotherapy with patients analyzed according to the treatment they received (TheraSphere +Chemo=187 and Chemo only=207) with the exception of All Cause Mortality. For All Cause Mortality the Intent to Treat Population was utilized (TheraSphere + Chemo= 215 and Chemo only =213).