Trial Outcomes & Findings for Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer (NCT NCT03642067)

NCT ID: NCT03642067

Last Updated: 2025-06-15

Results Overview

ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-06-15

Participant Flow

Participant milestones

Measure	Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort C: Colorectal Cancer With no Biomarker Evaluation Required Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg) on day 1 of each 28 day cycle.
Overall Study STARTED	12	15	32
Overall Study COMPLETED	12	15	31
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

Baseline characteristics by cohort

Measure	Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer n=12 Participants Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer n=15 Participants Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort C: Colorectal Cancer With no Biomarker Evaluation Required n=32 Participants Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg) on day 1 of each 28 day cycle.	Total n=59 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants	51 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants	56 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.

Outcome measures

Measure	Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer n=12 Participants Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer n=15 Participants Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort C: Colorectal Cancer With no Biomarker Evaluation Required n=32 Participants Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg) on day 1 of each 28 day cycle.
Objective Response Rate (ORR)	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 months

Defined using NCI CTCAE v5.0

Outcome measures

Measure	Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer n=12 Participants Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer n=15 Participants Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort C: Colorectal Cancer With no Biomarker Evaluation Required n=32 Participants Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg) on day 1 of each 28 day cycle.
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation	0 Participants	0 Participants	0 Participants

Adverse Events

Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer

Serious events: 6 serious events

Other events: 12 other events

Deaths: 12 deaths

Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer

Serious events: 12 serious events

Other events: 15 other events

Deaths: 15 deaths

Cohort C: Colorectal Cancer With no Biomarker Evaluation Required

Serious events: 11 serious events

Other events: 32 other events

Deaths: 26 deaths

Serious adverse events

Measure	Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer n=12 participants at risk Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer n=15 participants at risk Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort C: Colorectal Cancer With no Biomarker Evaluation Required n=32 participants at risk Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg) on day 1 of each 28 day cycle.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Acidosis	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Acute kidney injury	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Endocrine disorders Adrenal Insufficiency	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Blood and lymphatic system disorders Anemia	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Vascular disorders Arteriovenous malformation	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Ascites	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Hepatobiliary disorders Biliary obstruction	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Hepatobiliary disorders Cholangitis	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Hepatobiliary disorders Cholestatic hepatocellular liver injury	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Colitis	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Disease progression	41.7% 5/12 • Number of events 5 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	26.7% 4/15 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Infection, C. Difficile	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Infection, COVID-19	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Intestinal obstruction	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 7 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Obstructive hydrocephalus	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Pancreatitis	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Pyelonephritis	8.3% 1/12 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Rectal Pain	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Ruptured bowel	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Seizures	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Sepsis	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Urinary Tract Infection	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Urinary tract obstruction	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	20.0% 3/15 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Fever	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.

Other adverse events

Measure	Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer n=12 participants at risk Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer n=15 participants at risk Participants received 480mg Nivolumab and 160mg Relatlimab on day 1 of each 28 day cycle.	Cohort C: Colorectal Cancer With no Biomarker Evaluation Required n=32 participants at risk Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg) on day 1 of each 28 day cycle.
General disorders Edema, Localized	8.3% 1/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Rectal pain	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Abdominal pain	33.3% 4/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	33.3% 5/15 • Number of events 7 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	28.1% 9/32 • Number of events 12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Abscess	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Acne	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Endocrine disorders Adrenal Insufficiency	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Alanine aminotransferase increased	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Alkaline phosphatase increased	25.0% 3/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Blood and lymphatic system disorders Anemia	25.0% 3/12 • Number of events 6 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Injury, poisoning and procedural complications Ankle fracture	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Anorexia	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	53.3% 8/15 • Number of events 9 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	25.0% 8/32 • Number of events 8 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Psychiatric disorders Anxiety	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Ascites	25.0% 3/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Aspartate aminotransferase increased	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Musculoskeletal and connective tissue disorders Back pain	33.3% 4/12 • Number of events 5 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	12.5% 4/32 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Bacteremia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Belching	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Bloating	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Blood bilirubin increased	25.0% 3/12 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Blood in stool	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Eye disorders Blurred vision	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Cardiac disorders Cardiac troponin T increased	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Chest Congestion	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Chills	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	21.9% 7/32 • Number of events 7 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Psychiatric disorders Confusion	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Eye disorders Conjunctivitis	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Constipation	33.3% 4/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	26.7% 4/15 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	21.9% 7/32 • Number of events 8 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 2/12 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	25.0% 8/32 • Number of events 8 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations COVID infection	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Creatinine increased	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Psychiatric disorders Depression	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Diarrhea	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	26.7% 4/15 • Number of events 5 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	21.9% 7/32 • Number of events 10 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Dizziness	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Dry mouth	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Dysgeusia	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Dysuria	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Ear and labyrinth disorders Ear blockage	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Ear and labyrinth disorders Ear pain	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Edema limbs	25.0% 3/12 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	33.3% 5/15 • Number of events 6 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Injury, poisoning and procedural complications Fall	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Fatigue	33.3% 4/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	26.7% 4/15 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	46.9% 15/32 • Number of events 17 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Fever	25.0% 3/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	33.3% 5/15 • Number of events 7 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	12.5% 4/32 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Flatulence	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Flu like symptoms	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Injury, poisoning and procedural complications Fracture	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	20.0% 3/15 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Headache	25.0% 3/12 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Hematuria	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Herniated Disk	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Hyperglycemia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Hyperhidrosis	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Hyperkalemia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Hypermagnesemia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Vascular disorders Hypertension	33.3% 4/12 • Number of events 5 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	20.0% 3/15 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Endocrine disorders Hyperthyroidism	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Hypoalbuminemia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Hypokalemia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Metabolism and nutrition disorders Hyponatremia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Vascular disorders Hypotension	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Endocrine disorders Hypothyroidism	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	18.8% 6/32 • Number of events 8 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Infection, H. Pylori	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	9.4% 3/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Psychiatric disorders Insomnia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	12.5% 4/32 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Lipase increased	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Lung infection	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Lymphocyte count decreased	25.0% 3/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Malodorous urine	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Mucositis oral	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Nail changes	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	46.7% 7/15 • Number of events 9 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	15.6% 5/32 • Number of events 5 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Musculoskeletal and connective tissue disorders Neck pain	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Nodule, skin	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Non-cardiac chest pain	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
General disorders Pain	25.0% 3/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	43.8% 14/32 • Number of events 20 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Pallor	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Cardiac disorders Palpitations	8.3% 1/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Papular urticaria	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Paresthesia	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Peripheral sensory neuropathy	8.3% 1/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Proctitis	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	21.9% 7/32 • Number of events 11 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	20.0% 3/15 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	15.6% 5/32 • Number of events 6 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Rectal anastomotic leak	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Rectal Bleeding	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Rectal tenesmus	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Psychiatric disorders Restless Leg Syndrome	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Musculoskeletal and connective tissue disorders Shoulder pain	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Sialorrhea	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Cardiac disorders Sinus bradycardia	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Cardiac disorders Sinus tachycardia	33.3% 4/12 • Number of events 6 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	40.0% 6/15 • Number of events 8 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Sinusitis	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Nervous system disorders Somnolence	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	26.7% 4/15 • Number of events 5 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Vascular disorders Thromboembolic event	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 3 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Thrush	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Ear and labyrinth disorders Tinnitus	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Toothache	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Urinary frequency	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Urinary Hesitancy	8.3% 1/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Urinary incontinence	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Urinary retention	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Urinary tract infection	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	26.7% 4/15 • Number of events 5 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Urinary urgency	8.3% 1/12 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/15 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Renal and urinary disorders Urine discoloration	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Infections and infestations Vaginal infection	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Eye disorders Vision decreased	0.00% 0/12 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	0.00% 0/32 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Gastrointestinal disorders Vomiting	25.0% 3/12 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	20.0% 3/15 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	21.9% 7/32 • Number of events 11 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Weight gain	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	13.3% 2/15 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.2% 2/32 • Number of events 4 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Weight loss	41.7% 5/12 • Number of events 5 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	53.3% 8/15 • Number of events 11 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	43.8% 14/32 • Number of events 19 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.
Investigations Thyroid stimulating hormone, increased	16.7% 2/12 • Number of events 2 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	6.7% 1/15 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.	3.1% 1/32 • Number of events 1 • Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months. This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for adverse event reporting.

Additional Information

Dung Le, MD

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 443-287-0002

Email: dle@jhmi.edu

Results disclosure agreements

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