Trial Outcomes & Findings for SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver (NCT NCT01473004)

NCT ID: NCT01473004

Last Updated: 2025-11-14

Results Overview

Evaluation of clinical benefit includes status of complete and partial response as well as stable disease

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: 3 months post final treatment, an average of 4 months
• Results posted on: 2025-11-14

Participant Flow

Participant milestones

Measure	Group A - No Prior Embolization no prior intra-hepatic arterial treatment	Group B - Prior Embolization one prior hepatic trans-arterial embolization treatment
Overall Study STARTED	24	24
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Group A - No Prior Embolization no prior intra-hepatic arterial treatment	Group B - Prior Embolization one prior hepatic trans-arterial embolization treatment
Overall Study Incomplete Lobar Treatment	1	0

Baseline Characteristics

SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver

Baseline characteristics by cohort

Measure	Group A: no Prior Intra-hepatic Arterial Treatment n=24 Participants Patients with no prior intra-hepatic arterial treatment will be treated with intra-hepatic arterial infusion of Yttrium-90 radioactive microspheres (SIR-Spheres® microspheres). Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.	Group B: One Prior Hepatic Trans-arterial Embolization Treatment n=24 Participants Patients with one prior hepatic trans-arterial embolization treatment will be treated with intra-hepatic arterial infusion of Yttrium-90 radioactive microspheres (SIR-Spheres® microspheres). Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.	Total n=48 Participants Total of all reporting groups
Age, Continuous	63 years n=10 Participants	59 years n=10 Participants	61 years n=20 Participants
Sex: Female, Male Female	10 Participants n=10 Participants	15 Participants n=10 Participants	25 Participants n=20 Participants
Sex: Female, Male Male	14 Participants n=10 Participants	9 Participants n=10 Participants	23 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=10 Participants	24 Participants n=10 Participants	47 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) White	24 Participants n=10 Participants	24 Participants n=10 Participants	48 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Region of Enrollment United States	24 participants n=10 Participants	24 participants n=10 Participants	48 participants n=20 Participants

PRIMARY outcome

Timeframe: 3 months post final treatment, an average of 4 months

Population: Clinical response in the liver metastases will be evaluated 3 months after the last radiosphere treatment using CT scans or MRI of the abdomen. The same modality must be used for serial measurements of target lesions. The sum of the longest diameter (LD) of up to 5 target liver lesions will be used to determine response.

Evaluation of clinical benefit includes status of complete and partial response as well as stable disease

Outcome measures

Measure	Group A - No Prior Embolization n=24 Participants no prior intra-hepatic arterial treatment	Group B - Prior Embolization n=24 Participants one prior hepatic trans-arterial embolization treatment
Clinical Benefit Rate of Previously Treated and Naive Patients Complete Response	0 Participants	0 Participants
Clinical Benefit Rate of Previously Treated and Naive Patients Partial Response	7 Participants	6 Participants
Clinical Benefit Rate of Previously Treated and Naive Patients Stable Disease	13 Participants	8 Participants
Clinical Benefit Rate of Previously Treated and Naive Patients Progressive Disease	3 Participants	10 Participants
Clinical Benefit Rate of Previously Treated and Naive Patients Not Evaluated	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 months post final treatment, an average of 4 months

Adverse events except for baseline symptoms will be collected from start of first treatment to 3 months post final treatment

Outcome measures

Measure	Group A - No Prior Embolization n=24 Participants no prior intra-hepatic arterial treatment	Group B - Prior Embolization n=24 Participants one prior hepatic trans-arterial embolization treatment
Number of Patients With Adverse Events	16 Participants	15 Participants

SECONDARY outcome

Timeframe: From date of first SIR-Spheres® administration until the date of death from any cause, assessed up to 6 years

Overall survival (OS) is measured from the start of the treatment to patient death. Date and cause of death will be recorded. The cause of death will be categorized as either cancer-related or cancer-unrelated.

Outcome measures

Measure	Group A - No Prior Embolization n=24 Participants no prior intra-hepatic arterial treatment	Group B - Prior Embolization n=24 Participants one prior hepatic trans-arterial embolization treatment
Overall Survival	18.9 months Interval 6.5 to 66.9	19.1 months Interval 4.8 to 68.4

SECONDARY outcome

Timeframe: 2 years post treatment, an average of 10 months

Period of time without progression of liver metastasis

Outcome measures

Measure	Group A - No Prior Embolization n=24 Participants no prior intra-hepatic arterial treatment	Group B - Prior Embolization n=24 Participants one prior hepatic trans-arterial embolization treatment
Progression Free Survival	8.1 months Interval 3.3 to 33.7	5.2 months Interval 2.9 to 22.0

SECONDARY outcome

Timeframe: 2 years post treatment, an average of 10 months

Population: One participant from Group A was not evaluated.

Outcome measures

Measure	Group A - No Prior Embolization n=23 Participants no prior intra-hepatic arterial treatment	Group B - Prior Embolization n=24 Participants one prior hepatic trans-arterial embolization treatment
Duration of Response	8.1 months Interval 6.4 to 11.8	5.2 months Interval 3.7 to 9.8

Adverse Events

Group A - No Prior Embolization

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Group B - Prior Embolization

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group A - No Prior Embolization n=24 participants at risk no prior intra-hepatic arterial treatment	Group B - Prior Embolization n=24 participants at risk one prior hepatic trans-arterial embolization treatment
Gastrointestinal disorders Abdominal Pain - Grade 1	45.8% 11/24 • Number of events 11 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Abdominal Pain - Grade 2	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Immune system disorders Allergy Antibiotic Eye Med - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Anorexia - Grade 1	20.8% 5/24 • Number of events 5 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Anorexia - Grade 2	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Musculoskeletal and connective tissue disorders Arthralgia - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Musculoskeletal and connective tissue disorders Arthralgia - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Musculoskeletal and connective tissue disorders Back Pain - Grade 1	20.8% 5/24 • Number of events 5 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Musculoskeletal and connective tissue disorders Back Pain - Grade 2	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Infections and infestations Bladder - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Infections and infestations Bladder - Grade 2	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Bloating/Flatulence - Grade 1	16.7% 4/24 • Number of events 4 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Bloating/Flatulence - Grade 2	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Blotchy Skin - Grade 1	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Injury, poisoning and procedural complications Bruising / hematoma groin - Grade 1	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Vascular disorders Bruise - Grade 1	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Burning RUQ - Grade 1	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Concentration Impairment - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Infections and infestations Conjunctivitis - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Infections and infestations Conjunctivitis - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Respiratory, thoracic and mediastinal disorders Cough - Grade 1	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Diarrhea/ Constipation - Grade 1	16.7% 4/24 • Number of events 4 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	25.0% 6/24 • Number of events 6 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Dizziness / Lightheadedness - Grade 1	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Dry Mouth - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Dysgeusia - Grade 1	16.7% 4/24 • Number of events 4 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Dyspepsia - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Dyspepsia - Grade 2	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Dysphagia - Grade 1	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Edema - Grade 1	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Eye disorders Eye Pain - Grade 2	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Fatigue - Grade 1	66.7% 16/24 • Number of events 16 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	62.5% 15/24 • Number of events 15 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Fatigue - Grade 2	25.0% 6/24 • Number of events 6 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Fever - Grade 1	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Infections and infestations Flu / Sinusitis / Cold - Grade 1	25.0% 6/24 • Number of events 6 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	25.0% 6/24 • Number of events 6 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Infections and infestations Flu / Sinusitis / Cold - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Food Poisoning - Grade 2	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Infections and infestations Fungal Skin Infection - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Gastritis - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders GERD/heartburn - Grade 1	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	16.7% 4/24 • Number of events 4 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders GERD/heartburn - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Headache - Grade 1	16.7% 4/24 • Number of events 4 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Headache - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Hiccups - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Hyperglycemia - Grade 1	16.7% 4/24 • Number of events 4 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	37.5% 9/24 • Number of events 9 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Hyperglycemia - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Hypersomnia - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Cardiac disorders Hypotension/Atrial Fibrillation - Grade 1	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Cardiac disorders Hypotension/Atrial Fibrillation - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Respiratory, thoracic and mediastinal disorders Hypoxia - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Psychiatric disorders Insomnia - Grade 1	33.3% 8/24 • Number of events 8 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Psychiatric disorders Insomnia - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Memory Impairment - Grade 1	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Psychiatric disorders Mood Alterations - Grade 1	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Psychiatric disorders Mood Alterations - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Nausea / Emesis - Grade 1	45.8% 11/24 • Number of events 11 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	50.0% 12/24 • Number of events 12 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Nausea / Emesis - Grade 2	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Gastrointestinal disorders Nausea / Emesis - Grade 3	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Night Sweats - Grade 1	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Pain - Grade 1	16.7% 4/24 • Number of events 4 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	37.5% 9/24 • Number of events 9 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Pain - Grade 2	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Pain - Grade 3	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Peripheral Neuropathy - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Cardiac disorders Pounding heartbeat/tightness - Grade 1	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Radiculitis - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Musculoskeletal and connective tissue disorders Rib pain - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Musculoskeletal and connective tissue disorders Right leg/ Shoulder / Neck Pain - Grade 1	12.5% 3/24 • Number of events 3 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Musculoskeletal and connective tissue disorders Right leg/ Shoulder / Neck Pain - Grade 3	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Nervous system disorders Sedation - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Respiratory, thoracic and mediastinal disorders Shortness of Breath - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Sore Throat - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Injury, poisoning and procedural complications Splenic Infarct - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Vascular disorders Thromboembolic Event - Grade 3	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Renal and urinary disorders Urinary Retention - Grade 2	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Vascular disorders Varicose Veins - Grade 1	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
Respiratory, thoracic and mediastinal disorders Voice Change (transient) - Grade 1	4.2% 1/24 • Number of events 1 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.
General disorders Weight Loss - Grade 1	8.3% 2/24 • Number of events 2 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.	0.00% 0/24 • From first SIR-Spheres® administration through 3 months post-final treatment, up to 6 years. Adverse events were monitored and graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Events were recorded from the first administration of SIR-Spheres® Yttrium-90 microspheres through 3 months after the final treatment. Only treatment-emergent adverse events were included.

Additional Information

Takami Sato, MD

Thomas Jefferson University

Phone: 215-955-8874

Email: Takami.Sato@jefferson.edu

Results disclosure agreements

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