Trial Outcomes & Findings for Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT02839707)

Last Updated: 2025-11-10

Results Overview

Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and will include estimates of the hazard ratios and the corresponding confidence intervals for the experimental regimen relative to the reference regimen, as well as Kaplan-Meier estimates of the survivorship function for each treatment group. Progression is defined by a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase from nadir, or an unequivocal increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2/PHASE3

Target enrollment

444 participants

Primary outcome timeframe

From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years

Results posted on

2025-11-10

Participant Flow

This study enrolled patients from June of 2017 to October of 2021.

Participant milestones

Participant milestones
Measure	Arm I (PLD, Atezolizumab) Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Phase I STARTED	17	8	8
Phase I COMPLETED	8	8	8
Phase I NOT COMPLETED	9	0	0
Phase II STARTED	80	80	80
Phase II COMPLETED	76	80	78
Phase II NOT COMPLETED	4	0	2
Phase III STARTED	27	72	72
Phase III COMPLETED	27	72	68
Phase III NOT COMPLETED	0	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (PLD, Atezolizumab) Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Phase I Not eligible for analysis	9	0
Phase II Not treated according to protocol	4	2
Phase III Not treated according to protocol	0	4

Baseline Characteristics

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (PLD, Atezolizumab) n=124 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Total n=444 Participants Total of all reporting groups
Age, Customized Age	62 years n=5 Participants	64 years n=20 Participants	63 years n=40 Participants	63 years n=28 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	160 Participants n=20 Participants	160 Participants n=40 Participants	444 Participants n=28 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=20 Participants	8 Participants n=40 Participants	29 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	113 Participants n=5 Participants	147 Participants n=20 Participants	149 Participants n=40 Participants	409 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants	6 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=28 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	7 Participants n=20 Participants	9 Participants n=40 Participants	22 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	14 Participants n=20 Participants	11 Participants n=40 Participants	35 Participants n=28 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants	133 Participants n=20 Participants	130 Participants n=40 Participants	367 Participants n=28 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants	2 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=20 Participants	9 Participants n=40 Participants	17 Participants n=28 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: Patients enrolled into safety stage 1 and 2

Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (CTCAE version 5.0 will be used beginning April 1, 2018). DLT will be assessed.

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=17 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=8 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=8 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years

Population: Eligible patients enrolled in Phase I and II.

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=88 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=88 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=88 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Progression Free Survival (PFS) (Phase II)	4.2 months Interval 3.4 to 5.6	7.6 months Interval 5.6 to 8.8	5.5 months Interval 3.9 to 7.3

PRIMARY outcome

Timeframe: From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years.

Population: Eligible patients enrolled in Phase I, II and III.

Will be assessed by RECIST v1.1 criteria and will include estimates of the hazard ratios and the corresponding confidence intervals for the experimental regimen relative to the reference regimen, as well as Kaplan-Meier estimates of the survivorship function for each treatment group. Progression is defined by a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase from nadir, or an unequivocal increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=115 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
PFS (Phase III)	4.0 months Interval 3.3 to 5.6	7.4 months Interval 5.7 to 7.8	5.6 months Interval 4.8 to 6.5

PRIMARY outcome

Timeframe: From study enrollment to the date of death regardless of the cause, assessed up to 5 years

Population: Eligible patients enrolled in Phase I, II and III.

OS will be evaluated by Kaplan Meier methods. The median survival and confidence intervals will be reported.

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=115 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Overall Survival (OS) (Phase III)	14.5 months Interval 10.7 to 18.7	14.9 months Interval 12.7 to 17.1	12.3 months Interval 11.4 to 15.2

SECONDARY outcome

Timeframe: Up to 5 years

Population: Eligible patients enrolled in Phase I and II.

Will be assessed by RECIST v1.1 criteria. Will be tabulated by treatment group, and 95% confidence intervals presented using Wilson's Score Method. Treatment arms will be compared using a likelihood ratio chi-square test. Progression is defined by a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase from nadir, or an unequivocal increase in a non-target lesion, or appearance of new lesions. For the definition of response: the responses are assessed as overall best response during the course of therapy. For partial response (PR), the sum of the longest diameters must decrease by at least 30%. For a complete response (CR), all evidence of disease must be gone and the CA125 levels must normalize. If a patient experiences a disease progression during treatment, this is classified as progressive disease (PD). If the patient neither progresses (PD) nor has a response (CR or PR), then the patient is classified as stable disease (SD).

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=88 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=88 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=88 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Objective Response Rate (ORR) (Partial or Complete Response) (Phase II)	14 Participants	30 Participants	21 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Eligible patients enrolled in Phase I, II and III.

Will be assessed by RECIST v1.1. Will be tabulated by treatment group, and 95% confidence intervals will be presented using Wilson's Score Method. Treatment arms will be compared using a likelihood ratio chi-square test. Progression is defined by a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase from nadir, or an unequivocal increase in a non-target lesion, or the appearance of new lesions. For the definition of response: the responses are assessed as overall best response during the course of therapy. For partial response (PR), the sum of the longest diameters must decrease by at least 30%. For a complete response (CR), all evidence of disease must be gone and the CA125 levels must normalize. If a patient experiences a disease progression during treatment, this is classified as progressive disease (PD). If the patient neither progresses (PD) nor has a response (CR or PR), then the patient is classified as stable disease (SD).

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=115 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
ORR (Partial or Complete Response) (Phase III)	19 Participants	55 Participants	38 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Eligible patients enrolled in safety stage 2 or phase II and received at least one treatment.

CTCAE V5.0 was used to classify adverse events. This endpoint will tabulate the number of patients who reported at least one adverse event of a grade 3 (or higher).

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=84 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=88 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=86 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Number of Patients With a Grade 3 (or Higher) Adverse Event (Phase II)	64 Participants	76 Participants	62 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Eligible patients enrolled in safety stage 2, phase II, and phase III and received at least one treatment.

CTCAE V5.0 was used to classify adverse events. This endpoint will tabulate the number of patients who reported at least one adverse event of a grade 3 (or higher).

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=111 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=160 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=154 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Number of Patients With a Grade 3 (or Higher) Adverse Event (Phase III)	79 Participants	133 Participants	110 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Eligible patients enrolled in Phase I, II and III and provided baseline and at least one follow-up assessments.

Patient reported outcomes are measured with the NFOSI-18 Disease-related physical symptoms subscale (DRS-P). The DRS-P subscale comprises 9 items with each item ranging from 0 to 4. The total score of the DRS-P subscale ranges 0 - 36 with a larger score suggesting preferred/better health states.

Outcome measures

Outcome measures
Measure	Arm I (PLD, Atezolizumab) n=87 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=146 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=141 Participants Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Patient Reported Outcomes 8 weeks	25.9 score Standard Deviation 6.3	25.8 score Standard Deviation 6.1	26.0 score Standard Deviation 5.5
Patient Reported Outcomes 16 weeks	26.8 score Standard Deviation 6.2	26.3 score Standard Deviation 6.3	26.0 score Standard Deviation 5.6
Patient Reported Outcomes 24 weeks	26.8 score Standard Deviation 6.1	25.7 score Standard Deviation 7.0	26.1 score Standard Deviation 5.7
Patient Reported Outcomes 32 weeks	26.8 score Standard Deviation 6.5	26.5 score Standard Deviation 6.3	26.4 score Standard Deviation 6.2
Patient Reported Outcomes 40 weeks	27.1 score Standard Deviation 6.8	27.3 score Standard Deviation 5.6	25.5 score Standard Deviation 5.9
Patient Reported Outcomes 48 weeks	26.8 score Standard Deviation 6.1	26.1 score Standard Deviation 6.1	25.6 score Standard Deviation 6.7
Patient Reported Outcomes 60 weeks	26.9 score Standard Deviation 6.4	26.7 score Standard Deviation 5.8	26.0 score Standard Deviation 5.4
Patient Reported Outcomes 72 weeks	27.5 score Standard Deviation 4.9	26.9 score Standard Deviation 5.4	28.8 score Standard Deviation 6.0
Patient Reported Outcomes 84 weeks	26.4 score Standard Deviation 5.6	27.1 score Standard Deviation 6.1	27.4 score Standard Deviation 5.5
Patient Reported Outcomes 96 weeks	26.6 score Standard Deviation 6.0	26.3 score Standard Deviation 6.4	29.5 score Standard Deviation 4.1
Patient Reported Outcomes 108 weeks	27.3 score Standard Deviation 6.2	25.0 score Standard Deviation 8.0	28.7 score Standard Deviation 5.6
Patient Reported Outcomes Baseline	26.8 score Standard Deviation 5.9	26.1 score Standard Deviation 6.7	26.3 score Standard Deviation 6.7

Adverse Events

Arm I (PLD, Atezolizumab)

Serious events: 44 serious events

Other events: 106 other events

Deaths: 104 deaths

Arm II (PLD, Bevacizumab, Atezolizumab)

Serious events: 86 serious events

Other events: 159 other events

Deaths: 123 deaths

Arm III (PLD, Bevacizumab)

Serious events: 73 serious events

Other events: 150 other events

Deaths: 134 deaths

Serious adverse events

Other adverse events

Additional Information

Christopher Purdy on behalf of Mike Sill, PhD

NRG Oncology

Phone: (716) 845-1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Arm I (PLD, Atezolizumab) n=111 participants at risk Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=160 participants at risk Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=154 participants at risk Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Blood and lymphatic system disorders Anemia	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Blood and lymphatic system disorders Febrile neutropenia	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Atrial fibrillation	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Heart failure	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.3% 2/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Myocardial infarction	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Sinus bradycardia	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Supraventricular tachycardia	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Ear and labyrinth disorders Vertigo	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Endocrine disorders Adrenal insufficiency	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Endocrine disorders Hyperthyroidism	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Eye disorders - Other, specify	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Abdominal distension	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Abdominal pain	7.2% 8/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	5.6% 9/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	2.6% 4/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Ascites	3.6% 4/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Colitis	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Colonic obstruction	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Colonic perforation	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.3% 2/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Constipation	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.3% 2/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Diarrhea	2.7% 3/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Dysphagia	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Enterocolitis	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Esophagitis	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Gastric perforation	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Nausea	4.5% 5/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	5.0% 8/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Gastrointestinal fistula	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Ileal obstruction	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Ileus	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Jejunal obstruction	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Mucositis oral	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	5.6% 9/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Obstruction gastric	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Oral pain	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Pancreatitis	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.

Other adverse events
Measure	Arm I (PLD, Atezolizumab) n=111 participants at risk Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021) Atezolizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (PLD, Bevacizumab, Atezolizumab) n=160 participants at risk Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study. Atezolizumab: Given IV Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies	Arm III (PLD, Bevacizumab) n=154 participants at risk Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study. Bevacizumab: Given IV Computed Tomography: Undergo CT Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies
Blood and lymphatic system disorders Anemia	49.5% 55/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	38.8% 62/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	40.9% 63/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Blood and lymphatic system disorders Febrile neutropenia	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Blood and lymphatic system disorders Hemolysis	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Atrial fibrillation	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Chest pain - cardiac	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Heart failure	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	3.1% 5/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Myocardial infarction	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Palpitations	1.8% 2/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.3% 2/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Pericardial effusion	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Sinus bradycardia	2.7% 3/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	4.4% 7/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Sinus tachycardia	3.6% 4/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	7.5% 12/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	3.2% 5/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Cardiac disorders Supraventricular tachycardia	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Ear and labyrinth disorders Ear pain	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Ear and labyrinth disorders Hearing impaired	1.8% 2/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Ear and labyrinth disorders Middle ear inflammation	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Ear and labyrinth disorders Tinnitus	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	2.5% 4/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.3% 2/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Ear and labyrinth disorders Vertigo	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	2.6% 4/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Endocrine disorders Adrenal insufficiency	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Endocrine disorders Hyperthyroidism	9.9% 11/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	8.8% 14/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.3% 2/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Endocrine disorders Hypothyroidism	15.3% 17/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	23.8% 38/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	7.1% 11/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Blurred vision	5.4% 6/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	8.1% 13/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	5.8% 9/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Cataract	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Dry eye	1.8% 2/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	3.1% 5/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Eye pain	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Flashing lights	0.90% 1/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Floaters	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.2% 2/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Glaucoma	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Periorbital edema	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.3% 2/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Photophobia	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Retinal tear	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.65% 1/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Eye disorders Watering eyes	1.8% 2/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Abdominal distension	9.0% 10/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	3.1% 5/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	5.2% 8/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Abdominal pain	40.5% 45/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	29.4% 47/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	34.4% 53/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.62% 1/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	0.00% 0/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Ascites	14.4% 16/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	4.4% 7/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	4.5% 7/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Bloating	13.5% 15/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	8.8% 14/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	8.4% 13/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.
Gastrointestinal disorders Colitis	1.8% 2/111 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/160 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.	1.9% 3/154 • Up to 5 years The maximum grade of each adverse event (AE) by system organ class and term (CTCAE version 5.0) will be tabulated for those individuals who at least initiate study treatment. The number and percent of subjects will be tabulated by the term. In order to report events potentially related to treatment, the SAE/AE population is restricted to subjects receiving treatment. The all-cause mortality is related to overall survival, which is an efficacy measure, and therefore the population is ITT.