Trial Outcomes & Findings for Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer (NCT NCT01556490)

NCT ID: NCT01556490

Last Updated: 2023-11-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

526 participants

Primary outcome timeframe

From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

Results posted on

2023-11-08

Participant Flow

In total 526 participants were randomized to either the Control Group (Sorafenib + Standard of Care) or the Treatment Group (TheraSphere + Sorafenib + Standard of Care).

The Overall Survival (OS) efficacy endpoints analyzed on the modified Intent-To-Treat (mITT) population, comprising 481/526 randomized patients who met eligibility criteria.

Participant milestones

Participant milestones
Measure	Sorafenib + Standard of Care Control group - Modified Intent-to-Treat (mITT)	TheraSphere + Sorafenib + Standard of Care Treatment group - Modified Intent-to-Treat (mITT) TheraSphere: Yttrium 90 microspheres
Randomized Patients Summary STARTED	263	263
Randomized Patients Summary COMPLETED	241	240
Randomized Patients Summary NOT COMPLETED	22	23
Overall Survival (OS) STARTED	241	240
Overall Survival (OS) COMPLETED	229	222
Overall Survival (OS) NOT COMPLETED	12	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib + Standard of Care Control group - Modified Intent-to-Treat (mITT)	TheraSphere + Sorafenib + Standard of Care Treatment group - Modified Intent-to-Treat (mITT) TheraSphere: Yttrium 90 microspheres
Randomized Patients Summary Protocol Violation	22	23
Overall Survival (OS) Untreated Patients who Discontinued/Completed from Study	12	18

Baseline Characteristics

Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib + Standard of Care n=241 Participants Control group: Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=240 Participants Treatment group: Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres	Total n=481 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	130 Participants n=5 Participants	120 Participants n=7 Participants	250 Participants n=5 Participants
Age, Categorical >=65 years	111 Participants n=5 Participants	120 Participants n=7 Participants	231 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	215 Participants n=5 Participants	210 Participants n=7 Participants	425 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=5 Participants	136 Participants n=7 Participants	280 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	91 Participants n=5 Participants	100 Participants n=7 Participants	191 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	55 Participants n=5 Participants	52 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	79 Participants n=7 Participants	174 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	85 Participants n=5 Participants	97 Participants n=7 Participants	182 Participants n=5 Participants
Region of Enrollment Canada	22 participants n=5 Participants	21 participants n=7 Participants	43 participants n=5 Participants
Region of Enrollment South Korea	47 participants n=5 Participants	43 participants n=7 Participants	90 participants n=5 Participants
Region of Enrollment Belgium	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	34 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United Kingdom	28 participants n=5 Participants	22 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment France	80 participants n=5 Participants	94 participants n=7 Participants	174 participants n=5 Participants
Region of Enrollment Germany	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Spain	28 participants n=5 Participants	15 participants n=7 Participants	43 participants n=5 Participants
Region of Enrollment Hong Kong	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Singapore	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

Population: All participants were analyzed, and the count of participants is reporting the number of events (deaths).

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

Outcome measures

Outcome measures
Measure	Sorafenib + Standard of Care n=241 Participants Control group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=240 Participants Treatment group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres
Overall Survival (OS) Results Are Based on the Modified Intent-to-treat (mITT)	200 Participants	206 Participants

PRIMARY outcome

Timeframe: From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

Per Protocol = subset of the mITT population excluding patients with major protocol deviations which may affect the efficacy evaluation.

Outcome measures

Outcome measures
Measure	Sorafenib + Standard of Care n=218 Participants Control group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=104 Participants Treatment group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres
Overall Survival (OS) Per Protocol (PP) Population	13.2 Months Interval 11.9 to 14.8	13.8 Months Interval 11.1 to 20.3

SECONDARY outcome

Timeframe: From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

Time to progression (TTP) will be calculated as the interval between the randomization date and the date of first disease progression, including the appearance of new lesion(s) (per RECIST 1.1) and death for any cause or of last contact for patients alive.

Outcome measures

Outcome measures
Measure	Sorafenib + Standard of Care n=241 Participants Control group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=240 Participants Treatment group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres
Time to Progression (TTP) From Time of Randomization Based on Investigator, According RECIST Criteria.	5.6 Months Interval 5.5 to 8.0	8.1 Months Interval 6.7 to 11.0

SECONDARY outcome

Timeframe: From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

Time to progression (TTP) will be calculated as the interval between the randomization date and the date of first disease progression, including the appearance of new lesion(s) and death for any cause or of last contact for patients alive.

Outcome measures

Outcome measures
Measure	Sorafenib + Standard of Care n=241 Participants Control group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=240 Participants Treatment group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres
Time to Untreatable Progression (TTUP) From the Time of Randomization Based One or More of the Following: Investigator Assessment According to RECIST Criteria	8.0 Months Interval 5.6 to 11.2	12.2 Months Interval 9.5 to 16.5

SECONDARY outcome

Timeframe: From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months

Objective Response Rate by investigator determination per RECIST 1.1

Outcome measures

Outcome measures
Measure	Sorafenib + Standard of Care n=241 Participants Control group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=240 Participants Treatment group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres
Tumor Response	20 Participants	57 Participants

POST_HOC outcome

Timeframe: From time of randomization up to date of death or last date known to bealive (data cut-off 30Apr2022), an average of 16.3 months

Population: Percentages are based on the number of patients in each treatment group. A major protocol deviation is a deviation that may affect efficacy evaluation and results in removal of a patient from Per Protocol Population. Of the Major protocol deviations 156/159 patients had treatment related exclusions.

A modified Intention To Treat (mITT) Population was used to analyze all efficacy endpoints. This population is defined as randomized patients who met the study eligibility criteria at randomization. This outcome analysis is based on the mITT population, which includes patients with major protocol deviations.

Outcome measures

Outcome measures
Measure	Sorafenib + Standard of Care n=241 Participants Control group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=240 Participants Treatment group - Modified Intent-to-Treat (mITT): Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres
Summary of Protocol Deviations Patients with a Major Protocol Deviation	23 Participants	136 Participants
Summary of Protocol Deviations Patients with a Protocol Deviation	193 Participants	225 Participants

Adverse Events

Sorafenib + Standard of Care

Serious events: 111 serious events

Other events: 259 other events

Deaths: 239 deaths

TheraSphere + Sorafenib + Standard of Care

Serious events: 94 serious events

Other events: 189 other events

Deaths: 178 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib + Standard of Care n=274 participants at risk Control Group: Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=207 participants at risk Treatment Group: Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres
Blood and lymphatic system disorders Anaemia	2.2% 6/274 • Number of events 6 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Blood and lymphatic system disorders Bicytopenia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Blood and lymphatic system disorders Microcytic anaemia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Cardiac disorders Acute coronary syndrome	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Cardiac disorders Acute myocardial infarction	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Cardiac disorders Atrioventricular block	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Cardiac disorders Cardiac arrest	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Cardiac disorders Cardiac failure	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Cardiac disorders Cardiac failure congestive	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Cardiac disorders Supraventricular tachycardia	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Endocrine disorders Hyperparathyroidism	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Endocrine disorders Hyperthyroidism	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Abdominal pain	2.6% 7/274 • Number of events 7 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Ascites	1.8% 5/274 • Number of events 5 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	4.8% 10/207 • Number of events 12 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Colitis	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Constipation	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Diarrhoea	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Diverticulum intestinal	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Dysphagia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Gastric ileus	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Gastric ulcer	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Haematemesis	0.73% 2/274 • Number of events 3 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Intestinal ischaemia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Localised intraabdominal fluid collection	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Melaena	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Nausea	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Oesophageal haemorrhage	1.1% 3/274 • Number of events 3 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Oesophageal varices haemorrhage	1.5% 4/274 • Number of events 4 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Pancreatitis	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Pancreatitis acute	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 3 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Peritoneal haemorrhage	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.8% 5/274 • Number of events 5 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Vomiting	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Asthenia	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Disease progression	4.7% 13/274 • Number of events 13 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	6.8% 14/207 • Number of events 14 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Fatigue	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders General physical health deterioration	2.2% 6/274 • Number of events 7 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	2.4% 5/207 • Number of events 5 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Hyperthermia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Oedema peripheral	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Pain	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Pyrexia	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	1.4% 3/207 • Number of events 3 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Sudden death	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Ulcer haemorrhage	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Bile duct stone	0.36% 1/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Cholangitis	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Cholecystitis acute	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Hepatic failure	3.6% 10/274 • Number of events 10 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	4.8% 10/207 • Number of events 11 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Hepatic haemorrhage	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Hepatorenal syndrome	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Hyperbilirubinaemia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Jaundice	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Abdominal wall abscess	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Abscess intestinal	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Anal abscess	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Bacteraemia	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Brain abscess	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Bronchitis	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Cholecystitis infective	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Endocarditis bacterial	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Gastroenteritis	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Herpes zoster	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Influenza	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Liver abscess	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Lower respiratory tract infection	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Lung infection	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Neutropenic sepsis	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Peritoneal infection	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Peritonitis bacterial	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Pneumonia	0.73% 2/274 • Number of events 4 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Sepsis	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	1.4% 3/207 • Number of events 3 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Septic shock	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Infections and infestations Urinary tract infection	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Injury, poisoning and procedural complications Laceration	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Injury, poisoning and procedural complications Post embolisation syndrome	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Injury, poisoning and procedural complications Radiation hepatitis	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Acidosis	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Dehydration	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Diabetic foot	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Hypercalcaemia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Hyperglycaemia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Back pain	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Muscular weakness	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Pathological fracture	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver carcinoma ruptured	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Cerebral haematoma	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Cerebrovascular accident	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Encephalopathy	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Epilepsy	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Haemorrhagic stroke	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Hepatic encephalopathy	1.1% 3/274 • Number of events 3 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	3.9% 8/207 • Number of events 8 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Ischaemic cerebral infarction	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Ischaemic stroke	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Posterior reversible encephalopathy	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Sciatica	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Syncope	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Psychiatric disorders Confusional state	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Renal and urinary disorders Renal failure	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Renal and urinary disorders Renal failure acute	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	1.9% 4/207 • Number of events 4 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Respiratory, thoracic and mediastinal disorders Hepatic hydrothorax	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.97% 2/207 • Number of events 3 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	1.4% 3/207 • Number of events 3 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Psoriasis	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Rash	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/274 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.48% 1/207 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Skin ulcer	0.73% 2/274 • Number of events 2 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Surgical and medical procedures Therapeutic embolisation	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Vascular disorders Haemorrhage	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Vascular disorders Intra-abdominal haemorrhage	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Vascular disorders Thrombophlebitis	0.36% 1/274 • Number of events 1 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	0.00% 0/207 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.

Other adverse events

Other adverse events
Measure	Sorafenib + Standard of Care n=274 participants at risk Control Group: Standard-of-care sorafenib, with no added therapy	TheraSphere + Sorafenib + Standard of Care n=207 participants at risk Treatment Group: Standard-of-care sorafenib plus TheraSphere TheraSphere: Yttrium 90 microspheres
Blood and lymphatic system disorders Anaemia	6.6% 18/274 • Number of events 30 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	6.3% 13/207 • Number of events 20 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Blood and lymphatic system disorders Thrombocytopenia	4.0% 11/274 • Number of events 19 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	4.8% 10/207 • Number of events 11 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Abdominal pain	19.7% 54/274 • Number of events 67 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	20.3% 42/207 • Number of events 54 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Abdominal pain upper	6.6% 18/274 • Number of events 19 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	5.8% 12/207 • Number of events 13 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Ascites	13.9% 38/274 • Number of events 47 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	20.3% 42/207 • Number of events 48 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Constipation	13.1% 36/274 • Number of events 37 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	12.6% 26/207 • Number of events 29 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Diarrhoea	51.1% 140/274 • Number of events 234 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	30.0% 62/207 • Number of events 92 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Nausea	18.2% 50/274 • Number of events 60 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	21.3% 44/207 • Number of events 65 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Stomatitis	6.6% 18/274 • Number of events 23 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	3.9% 8/207 • Number of events 8 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Gastrointestinal disorders Vomiting	9.9% 27/274 • Number of events 31 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	12.6% 26/207 • Number of events 33 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Asthenia	8.0% 22/274 • Number of events 28 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	20.3% 42/207 • Number of events 60 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Fatigue	30.7% 84/274 • Number of events 128 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	33.3% 69/207 • Number of events 109 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Oedema peripheral	11.7% 32/274 • Number of events 40 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	12.6% 26/207 • Number of events 32 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Pain	4.4% 12/274 • Number of events 12 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	7.2% 15/207 • Number of events 15 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
General disorders Pyrexia	6.2% 17/274 • Number of events 24 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	11.1% 23/207 • Number of events 23 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Hepatobiliary disorders Hyperbilirubinaemia	3.3% 9/274 • Number of events 10 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	7.2% 15/207 • Number of events 18 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Investigations Aspartate aminotransferase increased	5.1% 14/274 • Number of events 15 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	4.8% 10/207 • Number of events 11 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Investigations Blood bilirubin increased	5.1% 14/274 • Number of events 24 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	10.6% 22/207 • Number of events 26 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Investigations Weight decreased	15.7% 43/274 • Number of events 70 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	14.5% 30/207 • Number of events 37 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Decreased appetite	31.8% 87/274 • Number of events 130 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	30.9% 64/207 • Number of events 90 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Hypoalbuminaemia	3.3% 9/274 • Number of events 19 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	5.3% 11/207 • Number of events 13 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Metabolism and nutrition disorders Hypokalaemia	2.6% 7/274 • Number of events 9 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	4.8% 10/207 • Number of events 17 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Back pain	8.8% 24/274 • Number of events 28 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	6.8% 14/207 • Number of events 14 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Muscle spasms	4.7% 13/274 • Number of events 13 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	3.9% 8/207 • Number of events 9 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 25/274 • Number of events 30 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	4.3% 9/207 • Number of events 12 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Nervous system disorders Headache	4.4% 12/274 • Number of events 12 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	5.3% 11/207 • Number of events 13 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Psychiatric disorders Insomnia	2.2% 6/274 • Number of events 6 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	6.3% 13/207 • Number of events 13 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.3% 20/274 • Number of events 20 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	5.8% 12/207 • Number of events 14 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.1% 14/274 • Number of events 18 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	5.8% 12/207 • Number of events 15 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.1% 14/274 • Number of events 17 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	5.3% 11/207 • Number of events 11 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Alopecia	13.1% 36/274 • Number of events 38 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	7.2% 15/207 • Number of events 15 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Dry skin	5.1% 14/274 • Number of events 16 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	4.3% 9/207 • Number of events 9 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Pruritus	6.9% 19/274 • Number of events 20 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	5.8% 12/207 • Number of events 14 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Skin and subcutaneous tissue disorders Rash	11.3% 31/274 • Number of events 40 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	8.7% 18/207 • Number of events 26 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.
Vascular disorders Hypertension	22.3% 61/274 • Number of events 91 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.	13.5% 28/207 • Number of events 35 • From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an estimated average of 16.3 months. Based on patients who received any amount of study treatment. For Control arm patients, AEs were documented for 30 days from the date of discontinuation. After this, only AEs related to TheraSphere were collected. AEs were summarized based on treatment received rather than treatment assigned; therefore, patients at risk is different compared to patients randomized and eligible (miTT). AE summaries include patients that were not in the mITT, therefore, certain events (e.g. deaths) may be higher.

Additional Information

Clinical Research Manager

Boston Scientific

Phone: 16138011844

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place