Trial Outcomes & Findings for Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma (NCT NCT04458922)

NCT ID: NCT04458922

Last Updated: 2025-12-04

Results Overview

ORR was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, which involves the following response definitions. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: Baseline until confirmation of progressive disease or response (complete or partial) as defined by RECIST v1.1, an average of 4 months.
• Results posted on: 2025-12-04

Participant Flow

Participant milestones

Measure	Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) Participants with clear cell sarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) Participants with conventional chondrosarcoma, grade 2 or 3, receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) Participants with dedifferentiated chondrosarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.
Overall Study STARTED	9	9	9
Overall Study COMPLETED	0	0	1
Overall Study NOT COMPLETED	9	9	8

Reasons for withdrawal

Measure	Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) Participants with clear cell sarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) Participants with conventional chondrosarcoma, grade 2 or 3, receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) Participants with dedifferentiated chondrosarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.
Overall Study Withdrawal by Subject	1	0	2
Overall Study Protocol -specified withdrawal criterion met	0	0	1
Overall Study Adverse Event	1	0	0
Overall Study Started new study	0	0	1
Overall Study Progressive disease	6	8	2
Overall Study Death	1	0	2
Overall Study Participant started chemotherapy	0	1	0

Baseline Characteristics

Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma

Baseline characteristics by cohort

Measure	Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) n=9 Participants Participants with clear cell sarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) n=9 Participants Participants with conventional chondrosarcoma, grade 2 or 3, receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) n=9 Participants Participants with dedifferentiated chondrosarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=3 Participants	7 Participants n=3 Participants	5 Participants n=6 Participants	21 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	2 Participants n=3 Participants	4 Participants n=6 Participants	6 Participants n=3 Participants
Age, Continuous	37.11 years STANDARD_DEVIATION 7.9 • n=3 Participants	52.89 years STANDARD_DEVIATION 11.4 • n=3 Participants	64.89 years STANDARD_DEVIATION 9.57 • n=6 Participants	51.63 years STANDARD_DEVIATION 14.89 • n=3 Participants
Sex: Female, Male Female	5 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=6 Participants	10 Participants n=3 Participants
Sex: Female, Male Male	4 Participants n=3 Participants	7 Participants n=3 Participants	6 Participants n=6 Participants	17 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	4 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=3 Participants	7 Participants n=3 Participants	9 Participants n=6 Participants	21 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	2 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	1 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	2 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	1 Participants n=3 Participants
Race (NIH/OMB) White	6 Participants n=3 Participants	6 Participants n=3 Participants	8 Participants n=6 Participants	20 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=3 Participants	2 Participants n=3 Participants	1 Participants n=6 Participants	4 Participants n=3 Participants
Region of Enrollment Canada	0 participants n=3 Participants	1 participants n=3 Participants	0 participants n=6 Participants	1 participants n=3 Participants
Region of Enrollment United States	9 participants n=3 Participants	8 participants n=3 Participants	9 participants n=6 Participants	26 participants n=3 Participants

PRIMARY outcome

Timeframe: Baseline until confirmation of progressive disease or response (complete or partial) as defined by RECIST v1.1, an average of 4 months.

ORR was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, which involves the following response definitions. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Measure	Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) n=9 Participants Participants with clear cell sarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) n=9 Participants Participants with conventional chondrosarcoma, grade 2 or 3, receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) n=9 Participants Participants with dedifferentiated chondrosarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.
Objective Response Rates (ORR) Complete Response	0 percentage of participants	0 percentage of participants	0 percentage of participants
Objective Response Rates (ORR) Partial Response	0 percentage of participants	0 percentage of participants	0 percentage of participants
Objective Response Rates (ORR) Stable Disease	33.33 percentage of participants	33.33 percentage of participants	33.33 percentage of participants
Objective Response Rates (ORR) Progressive Disease	55.56 percentage of participants	66.67 percentage of participants	44.44 percentage of participants
Objective Response Rates (ORR) Unknown (not assessed)	11.11 percentage of participants	0 percentage of participants	22.22 percentage of participants

SECONDARY outcome

Timeframe: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years

Population: The analysis population was to include all participants with an objective response (complete or partial). Because no objective responses were observed, there was no evaluable population and data were not collected.

Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and/or change in clinical symptoms. Progressive Disease (PD): is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years

PFS is the time interval from start of treatment to documented evidence of disease progression, measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, or death from any cause, whichever comes first. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Measure	Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) n=9 Participants Participants with clear cell sarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) n=9 Participants Participants with conventional chondrosarcoma, grade 2 or 3, receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) n=9 Participants Participants with dedifferentiated chondrosarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.
Progression-free Survival (PFS) Time	2.66 Months Interval 2.04 to The reason NA is listed as the upper limit of the confidence interval is that "Given the size and distribution of the sample set, there is not sufficient data to estimate the upper bounds."	3.22 Months Interval 2.07 to The reason NA is listed as the upper limit of the confidence interval is that "Given the size and distribution of the sample set, there is not sufficient data to estimate the upper bounds."	2.04 Months Interval 1.22 to The reason NA is listed as the upper limit of the confidence interval is that "Given the size and distribution of the sample set, there is not sufficient data to estimate the upper bounds."

SECONDARY outcome

Timeframe: Up to 3 years

Activated CD8+ T cells will be detected by multiplex immunofluorescence assays and will be defined by the expression of T cell receptor (TCR) activation (Zeta chain phosphorylation) or phosphorylated Zap70 (pY493); CD8+ cells present within the tumor section that are positive for these markers will be quantified.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) n=9 Participants Participants with clear cell sarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) n=9 Participants Participants with conventional chondrosarcoma, grade 2 or 3, receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) n=9 Participants Participants with dedifferentiated chondrosarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	9 Participants	8 Participants	9 Participants

Adverse Events

Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 1 deaths

Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS)

Serious events: 6 serious events

Other events: 9 other events

Deaths: 2 deaths

Serious adverse events

Measure	Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) n=9 participants at risk Participants with clear cell sarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) n=9 participants at risk Participants with conventional chondrosarcoma, grade 2 or 3, receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) n=9 participants at risk Participants with dedifferentiated chondrosarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.
General disorders Fever	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Immune system disorders Allergic reaction	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Chills	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Psychiatric disorders Confusion	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Death NOS	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Gluteal muscle myonecrosis	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, abscess- right thigh	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Vascular disorders Thromboembolic event	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Nervous system disorders Hydrocephalus	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Nervous system disorders Nervous system disorders - Other, Right sided facial droop	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Alkaline phosphatase increased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Disease progression	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Infections and infestations Eye infection	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Immune system disorders Immune system disorders - Other, systemic immune activation	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Alanine aminotransferase increased	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Aspartate aminotransferase increased	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Blood and lymphatic system disorders Anemia	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Cardiac disorders Chest pain - cardiac	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Eye disorders Eye pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypocalcemia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Nervous system disorders Neuralgia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Erythema of the skin on the right buttock	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Vascular disorders Hypotension	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Endocrine disorders Hypophysitis	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.

Other adverse events

Measure	Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) n=9 participants at risk Participants with clear cell sarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) n=9 participants at risk Participants with conventional chondrosarcoma, grade 2 or 3, receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.	Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) n=9 participants at risk Participants with dedifferentiated chondrosarcoma receive atezolizumab intravenous (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study.
Gastrointestinal disorders Abdominal pain	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Abdominal distension	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Endocrine disorders Adrenal insufficiency	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Alanine aminotransferase increased	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Alkaline phosphatase increased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Blood and lymphatic system disorders Anemia	77.8% 7/9 • Number of events 17 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	44.4% 4/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Anorexia	77.8% 7/9 • Number of events 11 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Psychiatric disorders Anxiety	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Aspartate aminotransferase increased	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Back pain	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Bloating	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Blood bilirubin increased	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Blood lactate dehydrogenase increased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Eye disorders Blurred vision	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Injury, poisoning and procedural complications Bruising	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations CD4 lymphocytes decreased	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Eye disorders Cataract	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Chest wall pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Chills	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Cholesterol high	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Nervous system disorders Concentration impairment	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Psychiatric disorders Confusion	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Constipation	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Psychiatric disorders Depression	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Diarrhea	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Dry mouth	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Dysphagia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Number of events 16 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	55.6% 5/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Edema face	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Edema limbs	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Edema trunk	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Blood and lymphatic system disorders Eosinophilia	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Reproductive system and breast disorders Erectile dysfunction	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Eye disorders Eye disorders - Other, macular edema	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Injury, poisoning and procedural complications Fall	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Fatigue	77.8% 7/9 • Number of events 16 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	66.7% 6/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Fever	55.6% 5/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Flu like symptoms	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Vascular disorders Flushing	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations GGT increased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Gastroesophageal reflux disease	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Gastrointestinal disorders - Other, appetite increased	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Generalized edema	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Psychiatric disorders Hallucinations	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Nervous system disorders Headache	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypercalcemia	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hyperglycemia	55.6% 5/9 • Number of events 21 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	44.4% 4/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Hyperhidrosis	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Vascular disorders Hypertension	33.3% 3/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Endocrine disorders Hyperthyroidism	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypertriglyceridemia	11.1% 1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	44.4% 4/9 • Number of events 9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypocalcemia	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypokalemia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hyponatremia	33.3% 3/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Vascular disorders Hypotension	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Endocrine disorders Hypothyroidism	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Psychiatric disorders Insomnia	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Investigations - Other, Chloride Decreased	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Investigations - Other, Hypoprotenemia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Investigations - Other, Total Protein Decreased	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Localized edema	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Lymphocyte count decreased	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Malaise	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, increased appetite	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Mucositis oral	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Muscle cramp	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Gluteal muscle myonecrosis	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Myotonic Jerking	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, knee pain	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, right hip	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Infections and infestations Nail infection	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Nausea	44.4% 4/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Neck pain	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Neutrophil count decreased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
General disorders Pain	33.3% 3/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 3/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 5 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Cardiac disorders Palpitations	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Nervous system disorders Paresthesia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Reproductive system and breast disorders Pelvic pain	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Eye disorders Periorbital edema	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Platelet count decreased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Postnasal drip	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Injury, poisoning and procedural complications Postoperative hemorrhage	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Nervous system disorders Presyncope	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Reproductive system and breast disorders Prostatic pain	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Rash acneiform	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Renal and urinary disorders Renal and urinary disorders - Other, Nocturia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, Swelling Lt inguinal area	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Serum amylase increased	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Cardiac disorders Sinus bradycardia	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Cardiac disorders Sinus tachycardia	44.4% 4/9 • Number of events 10 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Infections and infestations Sinusitis	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Blistering over bone hardware (LLE)	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, rash	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Surgical and medical procedures Surgical and medical procedures - Other, pleural catheter	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Vascular disorders Thromboembolic event	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Thyroid stimulating hormone increased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Renal and urinary disorders Urinary frequency	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Renal and urinary disorders Urinary incontinence	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Gastrointestinal disorders Vomiting	44.4% 4/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations Weight loss	44.4% 4/9 • Number of events 8 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.
Investigations White blood cell decreased	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	0.00% 0/9 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 were utilized for adverse event (AE) reporting. An adverse event that began in one cycle and resolved in another cycle is considered a single adverse event.

Additional Information

Alice P. Chen

National Cancer Institute

Phone: 240-781-3274

Email: chenali@mail.nih.gov

Results disclosure agreements

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

Restriction type: LTE60