Trial Outcomes & Findings for Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer (NCT NCT03348631)

NCT ID: NCT03348631

Last Updated: 2025-11-12

Results Overview

Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The statistic reported is the response rate (i.e. (total responses / total at risk) \* 100).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: Up to 6 months
• Results posted on: 2025-11-12

Participant Flow

Participant milestones

Measure	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Overall Study STARTED	19	43
Overall Study COMPLETED	16	42
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Overall Study Not Eligible, No treatment	0	1
Overall Study Not Eligible, Treated	2	0
Overall Study Eligible, No Treatment	1	0

Baseline Characteristics

Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer

Baseline characteristics by cohort

Measure	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients n=19 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients n=43 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Total n=62 Participants Total of all reporting groups
Age, Customized 20-29 years	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Age, Customized 30-39 years	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Age, Customized 40-49 years	0 Participants n=10 Participants	6 Participants n=10 Participants	6 Participants n=20 Participants
Age, Customized 50-59 years	5 Participants n=10 Participants	16 Participants n=10 Participants	21 Participants n=20 Participants
Age, Customized 60-69 years	11 Participants n=10 Participants	16 Participants n=10 Participants	27 Participants n=20 Participants
Age, Customized 70-79 years	1 Participants n=10 Participants	3 Participants n=10 Participants	4 Participants n=20 Participants
Age, Customized >= 80 years	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Sex: Female, Male Female	19 Participants n=10 Participants	43 Participants n=10 Participants	62 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=10 Participants	40 Participants n=10 Participants	59 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	3 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants
Race (NIH/OMB) White	16 Participants n=10 Participants	37 Participants n=10 Participants	53 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Eligible and Evaluable

Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The statistic reported is the response rate (i.e. (total responses / total at risk) * 100).

Outcome measures

Measure	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients n=16 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients n=42 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Tumor Response	0 Response/Patient (Percentage) Interval 0.0 to 15.0	4.7 Response/Patient (Percentage) Interval 0.6 to 15.8

SECONDARY outcome

Timeframe: Up to 6 months

Will be defined by RECIST v 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: Eligible and evaluable

Six-month progression free survival (clinical benefit rate). The clinical benefit rate is the total number (or percentage) of patients who had a complete response, or a partial response or who had stable disease for six months or more.

Outcome measures

Measure	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients n=16 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients n=42 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
6-month Progression Free Survival (Clinical Benefit Rate)	25 Percentage with 6-month PFS Interval 7.3 to 52.4	19 Percentage with 6-month PFS Interval 8.6 to 34.1

SECONDARY outcome

Timeframe: Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months).

Population: Eligible and Evaluable

Will be assessed according to grade of toxicity by organ or organ system. This will be reported by group (Endometrial or Ovarian). This study reported adverse events by CTCAE v5.0.

Outcome measures

Measure	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients n=16 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients n=42 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Number of Patients With a Grade 3 (or Higher) Adverse Events	6 Participants	20 Participants

SECONDARY outcome

Timeframe: Progression-free survival times were collected for a maximum of 30.0 months (interquartile range: 1.8 months, 5.5 months).

Population: Eligible and Evaluable

Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.

Outcome measures

Measure	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients n=16 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients n=42 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Progression-free Survival	2.05 months Interval 1.84 to 5.49	3.04 months Interval 2.04 to 4.37

SECONDARY outcome

Timeframe: Overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months).

Population: Eligible and evaluable

Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.

Outcome measures

Measure	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients n=16 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients n=42 Participants Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Overall Survival	25.3 months Interval 3.8 to The number of events was not sufficient for the estimation of this parameter (i.e. upper limit of the CI).	13.7 months Interval 8.0 to 22.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Will be assessed by immunohistochemistry. Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation).

Outcome measures

Outcome data not reported

Adverse Events

Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients

Serious events: 12 serious events

Other events: 40 other events

Deaths: 28 deaths

Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients

Serious events: 3 serious events

Other events: 15 other events

Deaths: 11 deaths

Serious adverse events

Measure	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients n=42 participants at risk Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients n=16 participants at risk Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Blood and lymphatic system disorders Anemia	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Cardiac disorders Cardiac arrest	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Abdominal pain	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Colonic obstruction	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Colonic perforation	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Constipation	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Nausea	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Vomiting	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Disease progression	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Fatigue	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Non-cardiac chest pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Abdominal infection	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Lung infection	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Sepsis	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Alanine aminotransferase increased	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Creatinine increased	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Dehydration	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hypercalcemia	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Ataxia	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Paresthesia	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Stroke	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Syncope	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Reproductive system and breast disorders Pelvic pain	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Vascular disorders Thromboembolic event	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.

Other adverse events

Measure	Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients n=42 participants at risk Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.	Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients n=16 participants at risk Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.
Blood and lymphatic system disorders Anemia	38.1% 16/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	43.8% 7/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Blood and lymphatic system disorders Lymph node pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Cardiac disorders Cardiac arrest	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Cardiac disorders Sinus tachycardia	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Ear and labyrinth disorders Tinnitus	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Endocrine disorders Hypothyroidism	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Eye disorders Blurred vision	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Eye disorders Eye pain	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Eye disorders Floaters	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Abdominal distension	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Abdominal pain	21.4% 9/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	31.2% 5/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Ascites	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Bloating	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Cheilitis	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Colonic obstruction	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Colonic perforation	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Constipation	23.8% 10/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	18.8% 3/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Diarrhea	21.4% 9/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	37.5% 6/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Dry mouth	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Dyspepsia	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Flatulence	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Gastroesophageal reflux disease	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Hemorrhoids	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Mucositis oral	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Nausea	54.8% 23/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	37.5% 6/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Rectal hemorrhage	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Toothache	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Gastrointestinal disorders Vomiting	31.0% 13/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	18.8% 3/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Chills	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Disease progression	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Edema limbs	9.5% 4/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Fatigue	47.6% 20/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	43.8% 7/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Fever	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Gait disturbance	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Malaise	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Non-cardiac chest pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
General disorders Pain	9.5% 4/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Hepatobiliary disorders Portal vein thrombosis	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Abdominal infection	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Herpes simplex reactivation	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Infections and infestations - Other, specify	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Lung infection	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Papulopustular rash	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Sepsis	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Sinusitis	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Skin infection	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Thrush	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Tooth infection	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Infections and infestations Urinary tract infection	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Injury, poisoning and procedural complications Bruising	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Activated partial thromboplastin time prolonged	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Alanine aminotransferase increased	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Alkaline phosphatase increased	11.9% 5/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Aspartate aminotransferase increased	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Blood bilirubin increased	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Cholesterol high	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Creatinine increased	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Lymphocyte count decreased	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Neutrophil count decreased	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Platelet count decreased	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Weight gain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations Weight loss	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Investigations White blood cell decreased	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Anorexia	28.6% 12/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	18.8% 3/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Dehydration	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hypercalcemia	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hyperglycemia	9.5% 4/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hyperkalemia	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hypoalbuminemia	14.3% 6/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hypocalcemia	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hypoglycemia	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hypokalemia	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hyponatremia	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Metabolism and nutrition disorders Hypophosphatemia	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Arthralgia	11.9% 5/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Back pain	16.7% 7/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Bone pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Flank pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Muscle cramp	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Myalgia	9.5% 4/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Neck pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 6/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Ataxia	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Dizziness	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Dysgeusia	14.3% 6/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	25.0% 4/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Headache	9.5% 4/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	25.0% 4/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Paresthesia	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Peripheral sensory neuropathy	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	18.8% 3/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Stroke	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Nervous system disorders Syncope	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Psychiatric disorders Anxiety	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Psychiatric disorders Confusion	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Psychiatric disorders Depression	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Psychiatric disorders Insomnia	9.5% 4/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Renal and urinary disorders Chronic kidney disease	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Renal and urinary disorders Dysuria	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Renal and urinary disorders Hematuria	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Renal and urinary disorders Urinary frequency	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Renal and urinary disorders Urinary incontinence	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Renal and urinary disorders Urinary retention	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Reproductive system and breast disorders Dyspareunia	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Reproductive system and breast disorders Pelvic pain	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Reproductive system and breast disorders Vaginal dryness	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Reproductive system and breast disorders Vaginal hemorrhage	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Cough	11.9% 5/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	18.8% 3/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Dyspnea	26.2% 11/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Respiratory, thoracic and mediastinal disorders Sore throat	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Skin and subcutaneous tissue disorders Alopecia	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Skin and subcutaneous tissue disorders Bullous dermatitis	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Skin and subcutaneous tissue disorders Nail changes	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Skin and subcutaneous tissue disorders Pruritus	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.5% 4/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.4% 1/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	0.00% 0/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Vascular disorders Hot flashes	4.8% 2/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Vascular disorders Hypertension	21.4% 9/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	12.5% 2/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.
Vascular disorders Thromboembolic event	7.1% 3/42 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.	6.2% 1/16 • Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months). This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for the collection of adverse events. Adverse events are described by system organ class (SOC) and term.

Additional Information

Christopher Purdy on behalf of Mike Sill, PhD

NRG Oncology

Phone: (716) 845-1300

Email: purdyc@nrgoncology.org

Results disclosure agreements

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

Restriction type: LTE60