Trial Outcomes & Findings for Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (NCT NCT04082364)

NCT ID: NCT04082364

Last Updated: 2025-06-08

Results Overview

Evaluation of adverse events and serious adverse events (Cohort A)

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 82 participants
• Primary outcome timeframe: Throughout the study, an average of 11 months.
• Results posted on: 2025-06-08

Participant Flow

Participant milestones

Measure	Part A: Chemotherapy-free Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Part B: Margetuximab, Retifanlimab, and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Part B: Margetuximab, Tebotelimab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Part B: Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Part B: Trastuzumab and Chemotherapy Arm Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Overall Study STARTED	48	10	6	10	8
Overall Study COMPLETED	17	7	3	2	2
Overall Study NOT COMPLETED	31	3	3	8	6

Reasons for withdrawal

Measure	Part A: Chemotherapy-free Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Part B: Margetuximab, Retifanlimab, and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Part B: Margetuximab, Tebotelimab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Part B: Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Part B: Trastuzumab and Chemotherapy Arm Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Overall Study Death	23	1	1	2	1
Overall Study Lost to Follow-up	1	0	0	0	1
Overall Study Physician Decision	1	1	0	2	1
Overall Study Withdrawal by Subject	1	1	0	0	1
Overall Study Follow-up terminated by Sponsor	5	0	2	3	2
Overall Study Disease progression	0	0	0	1	0

Baseline Characteristics

Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer

Baseline characteristics by cohort

Measure	Chemotherapy-free Arm n=48 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Margetuximab, Retifanlimab, and Chemotherapy Arm n=10 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm n=6 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm n=10 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Trastuzumab and Chemotherapy Arm n=8 Participants Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Total n=82 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 12.25 • n=5 Participants	61.8 years STANDARD_DEVIATION 7.64 • n=7 Participants	60.0 years STANDARD_DEVIATION 13.45 • n=5 Participants	60.5 years STANDARD_DEVIATION 13.70 • n=4 Participants	61.4 years STANDARD_DEVIATION 7.25 • n=21 Participants	62.1 years STANDARD_DEVIATION 11.45 • n=10 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	14 Participants n=10 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	7 Participants n=21 Participants	68 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	8 Participants n=21 Participants	78 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	8 Participants n=21 Participants	55 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	23 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Region of Enrollment South Korea	19 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	19 participants n=10 Participants
Region of Enrollment Singapore	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants
Region of Enrollment United States	24 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	24 participants n=10 Participants
Region of Enrollment China	0 participants n=5 Participants	8 participants n=7 Participants	5 participants n=5 Participants	9 participants n=4 Participants	7 participants n=21 Participants	29 participants n=10 Participants
Region of Enrollment Taiwan	0 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	5 participants n=10 Participants
Region of Enrollment Poland	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	2 participants n=10 Participants
Region of Enrollment Italy	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants

PRIMARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: All patients who receive at least one dose of study drug in Cohort A.

Evaluation of adverse events and serious adverse events (Cohort A)

Outcome measures

Measure	Chemotherapy-free Arm n=48 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 Any AE	47 Participants	—	—	—	—
Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 treatment-related AE	38 Participants	—	—	—	—
Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 severe AE	25 Participants	—	—	—	—
Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 severe treatment-related AE	12 Participants	—	—	—	—
Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 AE resulting in whole study treatment withdrawal	8 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: All participants in Cohort A who received at least one dose of study treatment and had baseline radiographic tumor assessment.

Percent of non MSI-H participants with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A ) based on investigator assessment.

CR is defined as the disappearance of all target and non-target lesions with no new lesions appearing PR is defined as >= to a 30% decrease in the sum of the longest dimensions of target lesions, non-progression of non- target lesions, with no new lesions appearing.

CR + PR = ORR

Outcome measures

Measure	Chemotherapy-free Arm n=48 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Objective Response Rate (ORR) for Non-microsatellite Instability-high (Non-MSI-H) Participants (Cohort A) Using Investigator-assessed Radiology Reviews	52.1 percentage of participants with CR or PR Interval 37.2 to 66.7	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: All participants who were assigned to treatment in Cohort A.

Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. (Cohorts A) based on investigator assessment

Outcome measures

Measure	Chemotherapy-free Arm n=48 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Median Progression-free Survival Using Investigator-assessed Radiology Reviews in Cohort A	9.8 months Interval 4.6 to 14.75	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: All participants in Cohort A who achieved a confirmed CR or PR.

Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first (Cohorts A)

Outcome measures

Measure	Chemotherapy-free Arm n=25 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Median Duration of Response in Cohort A Using Investigator-assessed Radiology Reviews	16.1 months Interval 9.0 to 21.91	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: All participants in Cohort A and B who received at least one dose of study treatment and had baseline radiographic tumor assessment.

Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment (Cohorts A and B)

Outcome measures

Measure	Chemotherapy-free Arm n=48 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm n=8 Participants Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm n=9 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm n=6 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm n=10 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Disease Control Rate	83.3 percent of participants Interval 69.8 to 92.5	87.5 percent of participants Interval 47.3 to 99.7	100 percent of participants Interval 66.4 to 100.0	100 percent of participants Interval 54.1 to 100.0	100 percent of participants Interval 69.2 to 100.0

SECONDARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: All participants in Cohort B who received at least one dose of study treatment and had baseline radiographic tumor assessment.

Proportion of participants with best overall response of CR plus PR per RECIST 1.1

Outcome measures

Measure	Chemotherapy-free Arm n=8 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm n=9 Participants Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm n=6 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm n=10 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
ORR for Cohort B	62.5 percent of participants with CR+PR Interval 24.5 to 91.5	88.9 percent of participants with CR+PR Interval 51.8 to 99.7	83.3 percent of participants with CR+PR Interval 35.9 to 99.6	90.0 percent of participants with CR+PR Interval 55.5 to 99.7	—

SECONDARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: Participants in Cohort A and B who received margetuximab as a component of study treatment.

Outcome measures

Measure	Chemotherapy-free Arm n=48 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm n=9 Participants Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm n=6 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm n=10 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab negative at baseline, negative post baseline	40 Participants	8 Participants	5 Participants	10 Participants	—
Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab Negative at baseline, positive at least once post baseline	5 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab Positive at baseline, as least once positive post baseline	2 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab Not done at baseline, negative post baseline	1 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab Negative at baseline, not done post baseline	0 Participants	0 Participants	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: Participants in Cohort A and B who received retifanlimab as a component of study treatment.

Outcome measures

Measure	Chemotherapy-free Arm n=48 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm n=9 Participants Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Number of Participants Who Have ADA to Retifanlimab not done at baseline, negative post baseline	1 Participants	0 Participants	—	—	—
Number of Participants Who Have ADA to Retifanlimab negative at baseline, negative post baseline	43 Participants	9 Participants	—	—	—
Number of Participants Who Have ADA to Retifanlimab negative at baseline, at least 1 positive post baseline	3 Participants	0 Participants	—	—	—
Number of Participants Who Have ADA to Retifanlimab Positive at baseline, and negative post baseline	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, an average of 11 months.

Population: Participants who received tebotelimab as a component of study treatment.

Outcome measures

Measure	Chemotherapy-free Arm n=6 Participants margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Trastuzumab and Chemotherapy Arm Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Retifanlimab, and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Number of Participants Who Have ADA to Tebotelimab Negative at baseline, negative post baseline	1 Participants	—	—	—	—
Number of Participants Who Have ADA to Tebotelimab Negative at baseline, positive at least once post baseline	4 Participants	—	—	—	—
Number of Participants Who Have ADA to Tebotelimab negative at baseline, not done post baseline	1 Participants	—	—	—	—

Adverse Events

Chemotherapy-free Arm

Serious events: 20 serious events

Other events: 47 other events

Deaths: 25 deaths

Margetuximab, Retifanlimab, and Chemotherapy Arm

Serious events: 4 serious events

Other events: 9 other events

Deaths: 1 deaths

Margetuximab, Tebotelimab and Chemotherapy Arm

Serious events: 5 serious events

Other events: 6 other events

Deaths: 1 deaths

Margetuximab and Chemotherapy Arm

Serious events: 4 serious events

Other events: 10 other events

Deaths: 2 deaths

Trastuzumab and Chemotherapy Arm

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Measure	Chemotherapy-free Arm n=48 participants at risk margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Margetuximab, Retifanlimab, and Chemotherapy Arm n=9 participants at risk margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm n=6 participants at risk margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm n=10 participants at risk margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Trastuzumab and Chemotherapy Arm n=8 participants at risk Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Blood and lymphatic system disorders Anaemia	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Endocrine disorders Thyroiditis subacute	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Dysphagia	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Abdominal pain	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Diarrhoea	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Gastric haemorrhage	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Ileus	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Oesophageal ulcer	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Pneumatosis intestinalis	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Small intestinal obstruction	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
General disorders Pyrexia	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
General disorders Asthenia	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
General disorders Chest discomfort	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Hepatobiliary disorders Biliary obstruction	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Hepatobiliary disorders Cholecystitis	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Hepatobiliary disorders Hepatic function abnormal	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Hepatobiliary disorders Hepatitis	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Hepatobiliary disorders Jaundice cholestatic	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Infections and infestations Urinary tract infection	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Infections and infestations Bacterial sepsis	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Infections and infestations Cystitis	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Infections and infestations Sepsis	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Infections and infestations Upper respiratory tract infection	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Platelet count decreased	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Diabetic ketoacidosis	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Failure to thrive	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Metabolic acidosis	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ovarian cyst	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Renal and urinary disorders Immune-mediated renal disorder	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Renal and urinary disorders Renal failure	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Renal and urinary disorders Urinary incontinence	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Combined pulmonary fibrosis and emphysema	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Infections and infestations Influenza A	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.

Other adverse events

Measure	Chemotherapy-free Arm n=48 participants at risk margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle.	Margetuximab, Retifanlimab, and Chemotherapy Arm n=9 participants at risk margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab, Tebotelimab and Chemotherapy Arm n=6 participants at risk margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Margetuximab and Chemotherapy Arm n=10 participants at risk margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6	Trastuzumab and Chemotherapy Arm n=8 participants at risk Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
Blood and lymphatic system disorders Anaemia	29.2% 14/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 3/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	83.3% 5/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	90.0% 9/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Blood and lymphatic system disorders Leukopenia	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 2/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	30.0% 3/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Blood and lymphatic system disorders Thrombocytopenia	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Endocrine disorders Hypothyroidism	10.4% 5/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	50.0% 3/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Diarrhoea	37.5% 18/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	44.4% 4/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 2/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	40.0% 4/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Nausea	33.3% 16/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	44.4% 4/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	30.0% 3/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Vomiting	33.3% 16/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 2/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	30.0% 3/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Constipation	16.7% 8/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Abdominal pain	20.8% 10/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Dyspepsia	14.6% 7/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Abdominal distension	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Gastrointestinal disorders Dysphagia	10.4% 5/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
General disorders Fatigue	29.2% 14/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
General disorders Pyrexia	18.8% 9/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
General disorders Oedema peripheral	18.8% 9/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
General disorders Asthenia	6.2% 3/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
General disorders Chills	6.2% 3/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Infections and infestations COVID-19	8.3% 4/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Infections and infestations Urinary tract infection	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Injury, poisoning and procedural complications Infusion related reaction	25.0% 12/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 3/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 2/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	40.0% 4/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Platelet count decreased	6.2% 3/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	77.8% 7/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	100.0% 6/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	70.0% 7/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	87.5% 7/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Neutrophil count decreased	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	77.8% 7/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	100.0% 6/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	100.0% 10/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	62.5% 5/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations White blood cell count decreased	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	77.8% 7/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	66.7% 4/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	80.0% 8/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	50.0% 4/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Aspartate aminotransferase increased	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	66.7% 6/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	50.0% 3/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	30.0% 3/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	50.0% 4/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Alanine aminotransferase increased	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	55.6% 5/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	50.0% 5/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	37.5% 3/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Weight decreased	18.8% 9/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	50.0% 3/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Blood bilirubin increased	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	40.0% 4/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	37.5% 3/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Gamma-glutamyltransferase increased	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 2/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	37.5% 3/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Ejection fraction decreased	6.2% 3/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Lymphocyte count decreased	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	30.0% 3/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Blood albumin decreased	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Blood alkaline phosphatase increased	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Blood creatinine increased	10.4% 5/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Investigations Protein total decreased	2.1% 1/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Decreased appetite	27.1% 13/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 3/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 2/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Hypoalbuminaemia	6.2% 3/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	66.7% 4/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	60.0% 6/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Hypokalaemia	16.7% 8/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 2/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	30.0% 3/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Hyponatraemia	8.3% 4/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	50.0% 3/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Metabolism and nutrition disorders Hypocalcaemia	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 2/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Musculoskeletal and connective tissue disorders Arthralgia	14.6% 7/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Musculoskeletal and connective tissue disorders Back pain	10.4% 5/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Nervous system disorders Dizziness	12.5% 6/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Nervous system disorders Neurotoxicity	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 3/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	40.0% 4/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Nervous system disorders Headache	12.5% 6/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Psychiatric disorders Insomnia	14.6% 7/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Psychiatric disorders Anxiety	10.4% 5/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Cough	14.6% 7/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	33.3% 3/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.8% 9/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 4/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Skin and subcutaneous tissue disorders Pruritus	20.8% 10/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	22.2% 2/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Skin and subcutaneous tissue disorders Rash	18.8% 9/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	12.5% 1/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	20.0% 2/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	25.0% 2/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.2% 2/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	11.1% 1/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	16.7% 1/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	10.0% 1/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
Vascular disorders Hypertension	12.5% 6/48 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/9 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/6 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/10 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.	0.00% 0/8 • AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.

Additional Information

Chief Medical Officer

MacroGenics, Inc.

Phone: 301-251-5172

Email: info@macrogenics.com

Results disclosure agreements

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

Restriction type: GT60