Trial Outcomes & Findings for Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer (NCT NCT02492711)

Last Updated: 2025-03-17

Results Overview

PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

624 participants

Primary outcome timeframe

Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.

Results posted on

2025-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Margetuximab Plus Chemotherapy Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy Margetuximab with or without chemotherapy administered as a 120 minute first infusion in Cycle 1 followed by 60-minute or 30-minute infusion in Cycle 2.
Overall Study STARTED	266	270	88
Overall Study Intent-to-treat (ITT) Population	266	270	88
Overall Study Safety Population	264	266	88
Overall Study COMPLETED	230	230	75
Overall Study NOT COMPLETED	36	40	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Margetuximab Plus Chemotherapy Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy Margetuximab with or without chemotherapy administered as a 120 minute first infusion in Cycle 1 followed by 60-minute or 30-minute infusion in Cycle 2.
Overall Study Adverse Event	9	9	2
Overall Study Death	3	3	0
Overall Study Withdrawal by Subject	10	16	5
Overall Study Physician Decision	10	6	4
Overall Study Lost to Follow-up	0	0	1
Overall Study study treatment delay	2	1	0
Overall Study change in chemotherapy	0	1	0
Overall Study never treated	2	4	0
Overall Study Other	0	0	1

Baseline Characteristics

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Margetuximab Plus Chemotherapy n=266 Participants Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy n=270 Participants Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy n=88 Participants Margetuximab with or without chemotherapy	Total n=624 Participants Total of all reporting groups
Age, Continuous	54.4 years STANDARD_DEVIATION 11.4 • n=5 Participants	55.7 years STANDARD_DEVIATION 11.5 • n=7 Participants	54.5 years STANDARD_DEVIATION 12.5 • n=5 Participants	55.1 years STANDARD_DEVIATION 11.5 • n=4 Participants
Sex: Female, Male Female	266 Participants n=5 Participants	267 Participants n=7 Participants	87 Participants n=5 Participants	620 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	30 Participants n=7 Participants	7 Participants n=5 Participants	53 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	217 Participants n=5 Participants	214 Participants n=7 Participants	75 Participants n=5 Participants	506 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	33 Participants n=5 Participants	26 Participants n=7 Participants	6 Participants n=5 Participants	65 Participants n=4 Participants
Race (NIH/OMB) other · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) other · Asian	20 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	43 Participants n=4 Participants
Race (NIH/OMB) other · Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) other · Black or African American	16 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) other · White	205 Participants n=5 Participants	222 Participants n=7 Participants	62 Participants n=5 Participants	489 Participants n=4 Participants
Race (NIH/OMB) other · More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) other · Unknown or Not Reported	24 Participants n=5 Participants	20 Participants n=7 Participants	0 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment Belgium	12 participants n=5 Participants	13 participants n=7 Participants	6 participants n=5 Participants	31 participants n=4 Participants
Region of Enrollment Canada	4 participants n=5 Participants	6 participants n=7 Participants	2 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment Czechia	4 participants n=5 Participants	8 participants n=7 Participants	0 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment France	22 participants n=5 Participants	13 participants n=7 Participants	5 participants n=5 Participants	40 participants n=4 Participants
Region of Enrollment Israel	12 participants n=5 Participants	20 participants n=7 Participants	9 participants n=5 Participants	41 participants n=4 Participants
Region of Enrollment Italy	41 participants n=5 Participants	33 participants n=7 Participants	15 participants n=5 Participants	89 participants n=4 Participants
Region of Enrollment South Korea	16 participants n=5 Participants	9 participants n=7 Participants	6 participants n=5 Participants	31 participants n=4 Participants
Region of Enrollment Portugal	5 participants n=5 Participants	6 participants n=7 Participants	2 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment Puerto Rico	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment United States	81 participants n=5 Participants	96 participants n=7 Participants	41 participants n=5 Participants	218 participants n=4 Participants
Region of Enrollment Austria	3 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Finland	3 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Denmark	9 participants n=5 Participants	7 participants n=7 Participants	0 participants n=5 Participants	16 participants n=4 Participants
Region of Enrollment Germany	10 participants n=5 Participants	7 participants n=7 Participants	0 participants n=5 Participants	17 participants n=4 Participants
Region of Enrollment Netherlands	3 participants n=5 Participants	4 participants n=7 Participants	0 participants n=5 Participants	7 participants n=4 Participants
Region of Enrollment Poland	4 participants n=5 Participants	6 participants n=7 Participants	0 participants n=5 Participants	10 participants n=4 Participants
Region of Enrollment Spain	27 participants n=5 Participants	34 participants n=7 Participants	0 participants n=5 Participants	61 participants n=4 Participants
Region of Enrollment United Kingdom	9 participants n=5 Participants	5 participants n=7 Participants	0 participants n=5 Participants	14 participants n=4 Participants

PRIMARY outcome

Timeframe: Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.

Population: The PFS outcome measure is calculated only for the randomized study efficacy population. The 88 participants in the sub-study were not part of the efficacy population

PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.

Outcome measures

Outcome measures
Measure	Margetuximab Plus Chemotherapy n=266 Participants Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy n=270 Participants Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy Margetuximab with or without chemotherap...	Margetuximab Stage A2 Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.	Margetuximab Stage B Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
Progression-free Survival (PFS) as Determined by Independent Radiological Review.	5.8 months Interval 5.52 to 6.97	4.9 months Interval 4.17 to 5.59	—	—	—

PRIMARY outcome

Timeframe: Throughout the study, average 21 months

Population: The OS outcome measure is calculated only for the randomized study efficacy population. The 88 participants in the sub-study were not part of the efficacy population

Overall survival is the time from randomization until death from any cause

Outcome measures

Outcome measures
Measure	Margetuximab Plus Chemotherapy n=266 Participants Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy n=270 Participants Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy Margetuximab with or without chemotherap...	Margetuximab Stage A2 Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.	Margetuximab Stage B Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).	21.6 months Interval 0.66 to 61.44	21.9 months Interval 0.07 to 64.53	—	—	—

PRIMARY outcome

Timeframe: 22 days

Population: Only patients in the infusion substudy are included in this outcome measure.

Incidence of Grade 3 or higher infusion-related reactions for patients receiving 60-minute or 30-minute infusions of margetuximab in Cycle 2 of treatment

Outcome measures

Outcome measures
Measure	Margetuximab Plus Chemotherapy Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy n=8 Participants Margetuximab with or without chemotherap...	Margetuximab Stage A2 n=9 Participants Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.	Margetuximab Stage B n=71 Participants Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
Number of Patients With Grade 3 or Higher Infusion Related Reactions	—	—	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.

Population: Analysis population consisted of all patient who had investigator-assessed responses to treatment as of the interim analysis. The outcome measure is calculated only for the randomized study population. The 88 participants in the sub-study were not part of the efficacy population.

Outcome measures

Outcome measures
Measure	Margetuximab Plus Chemotherapy n=160 Participants Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy n=177 Participants Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy Margetuximab with or without chemotherap...	Margetuximab Stage A2 Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.	Margetuximab Stage B Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators.	5.6 months Interval 5.06 to 6.67	4.2 months Interval 3.98 to 5.39	—	—	—

SECONDARY outcome

Timeframe: Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.

Population: Tumor response was assessed for patients with measurable disease at baseline. The cutoff data for analysis corresponds with the completion of enrollment. Detection of ORR requires at least 12 weeks, so the ORR may be underestimated. Outcome measure is calculated only for the randomized study population. The 88 participants in the sub-study were not part of the efficacy population.

Objective response rate includes all patients with either a complete response (CR) or a partial response (PR) to study treatment

Outcome measures

Outcome measures
Measure	Margetuximab Plus Chemotherapy n=262 Participants Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy n=262 Participants Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy Margetuximab with or without chemotherap...	Margetuximab Stage A2 Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.	Margetuximab Stage B Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review. PR	51 Participants	38 Participants	—	—	—
To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review. No response, progressive disease, not evaluable or not available	204 Participants	220 Participants	—	—	—
To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review. CR	7 Participants	4 Participants	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, average duration 6 months

Population: Only patients in the infusion substudy were evaluated for this outcome measure

Incidence of all grades of infusion-related reactions

Outcome measures

Outcome measures
Measure	Margetuximab Plus Chemotherapy Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy n=8 Participants Margetuximab with or without chemotherap...	Margetuximab Stage A2 n=9 Participants Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.	Margetuximab Stage B n=71 Participants Margetuximab administered as a 120 minute first infusion in Cycle 1 followed by 30 minute infusion in Cycle 2.
Infusion Rate Sub-study All Safety Infusion related reaction Cycle 1	—	—	1 participants	1 participants	16 participants
Infusion Rate Sub-study All Safety Infusion related reaction Cycle 2 or higher	—	—	0 participants	0 participants	2 participants
Infusion Rate Sub-study All Safety No infusion related reaction	—	—	7 participants	8 participants	55 participants

Adverse Events

Margetuximab Plus Chemotherapy

Serious events: 47 serious events

Other events: 213 other events

Deaths: 194 deaths

Trastuzumab Plus Chemotherapy

Serious events: 51 serious events

Other events: 210 other events

Deaths: 191 deaths

Margetuximab Infusion Substudy

Serious events: 17 serious events

Other events: 68 other events

Deaths: 56 deaths

Serious adverse events

Other adverse events

Additional Information

VP, Scientific Communications

TerSera Therapeutics LLC

Phone: 1-844-334-4035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Margetuximab Plus Chemotherapy n=264 participants at risk Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy n=266 participants at risk Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy n=88 participants at risk Margetuximab with or without chemotherapy
Blood and lymphatic system disorders Febrile neutropenia	1.5% 4/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	3.8% 10/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Blood and lymphatic system disorders Anaemia	0.76% 2/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.75% 2/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Blood and lymphatic system disorders Neutropenia	1.5% 4/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Acute myocardial infarction	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Atrial fibrillation	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Cardiac failure	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Ventricular tachycardia	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Abdominal pain	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	2.3% 2/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Constipation	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Diarrhoea	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Vomiting	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Colitis	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Dysphagia	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Impaired gastric emptying	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Irritable bowel syndrome	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Large intestine perforation	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Nausea	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Rectal haemorrhage	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Pyrexia	0.76% 2/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 3/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders General physical health deterioration	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Malaise	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Asthenia	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Chills	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Death	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Infusion site extravasation	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Non-cardiac chest pain	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Pain	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Immune system disorders Allergic oedema	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Pneumonia	1.5% 4/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	3.0% 8/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Cellulitis	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 3/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Urinary tract infection	0.76% 2/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.75% 2/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Influenza	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.75% 2/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Breast cellulitis	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.75% 2/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Bronchitis	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Septic shock	0.38% 1/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Acinetobacter infection	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Breast abscess	0.00% 0/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.38% 1/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.

Other adverse events
Measure	Margetuximab Plus Chemotherapy n=264 participants at risk Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Trastuzumab Plus Chemotherapy n=266 participants at risk Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.	Margetuximab Infusion Substudy n=88 participants at risk Margetuximab with or without chemotherapy
Blood and lymphatic system disorders Neutropenia	27.3% 72/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	20.3% 54/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	19.3% 17/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Blood and lymphatic system disorders Anaemia	18.2% 48/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	22.9% 61/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	20.5% 18/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 22/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	4.9% 13/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	3.4% 3/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Nausea	33.3% 88/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	32.7% 87/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	37.5% 33/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Diarrhoea	25.8% 68/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	25.2% 67/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	15.9% 14/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Constipation	18.9% 50/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	16.5% 44/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	22.7% 20/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Vomiting	20.8% 55/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	14.3% 38/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	21.6% 19/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Abdominal pain	9.5% 25/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	13.5% 36/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	10.2% 9/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Stomatitis	10.6% 28/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.9% 21/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	9.1% 8/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Abdominal pain upper	8.3% 22/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.9% 21/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Dyspepsia	6.1% 16/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.5% 20/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.0% 7/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Fatigue	42.4% 112/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	35.7% 95/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	27.3% 24/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Pyrexia	18.9% 50/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	12.8% 34/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	20.5% 18/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Asthenia	18.6% 49/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	12.0% 32/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.0% 7/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Oedema peripheral	8.0% 21/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	9.8% 26/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	5.7% 5/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Mucosal inflammation	9.8% 26/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	3.0% 8/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	3.4% 3/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Influenza like illness	6.8% 18/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	4.1% 11/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	5.7% 5/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Urinary tract infection	9.5% 25/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	9.8% 26/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	5.7% 5/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Upper respiratory tract infection	8.0% 21/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.6% 23/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.0% 7/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Nasopharyngitis	8.0% 21/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 19/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	1.1% 1/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Injury, poisoning and procedural complications Infusion related reaction	12.5% 33/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	3.4% 9/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	20.5% 18/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Investigations Neutrophil count decreased	12.1% 32/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	14.3% 38/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	13.6% 12/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Investigations Aspartate aminotransferase increased	8.3% 22/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	12.8% 34/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	13.6% 12/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Investigations Alanine aminotransferase increased	9.8% 26/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	9.8% 26/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	12.5% 11/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Investigations White blood cell count decreased	7.6% 20/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	9.8% 26/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	9.1% 8/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Investigations Weight decreased	6.1% 16/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	5.6% 15/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	10.2% 9/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Metabolism and nutrition disorders Decreased appetite	14.4% 38/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	14.3% 38/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	10.2% 9/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Metabolism and nutrition disorders Hypokalaemia	6.1% 16/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.9% 21/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	9.1% 8/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Musculoskeletal and connective tissue disorders Pain in extremity	12.1% 32/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	9.4% 25/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.0% 7/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Musculoskeletal and connective tissue disorders Arthralgia	10.6% 28/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.6% 23/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	11.4% 10/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Musculoskeletal and connective tissue disorders Back pain	8.7% 23/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	10.2% 27/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.0% 7/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Musculoskeletal and connective tissue disorders Myalgia	6.8% 18/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	6.0% 16/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	4.5% 4/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Musculoskeletal and connective tissue disorders Muscle spasms	6.4% 17/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	4.1% 11/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.0% 7/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Nervous system disorders Headache	18.9% 50/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	16.2% 43/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	12.5% 11/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Nervous system disorders Neuropathy peripheral	9.8% 26/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	10.5% 28/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.0% 7/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Nervous system disorders Dizziness	9.8% 26/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	6.4% 17/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	5.7% 5/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Nervous system disorders Dysgeusia	6.1% 16/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	5.6% 15/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	8.0% 7/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Nervous system disorders Peripheral sensory neuropathy	6.4% 17/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	4.9% 13/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	3.4% 3/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Psychiatric disorders Insomnia	5.7% 15/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	5.6% 15/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	6.8% 6/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Respiratory, thoracic and mediastinal disorders Cough	15.9% 42/264 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	12.4% 33/266 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	6.8% 6/88 • AEs were collected from the time of first dose through 30 days after the last dose, average 6 months. All-cause mortality was collected from the first dose until the primary completion date, average 2 years. AEs are based on physical exam, patient reports, and significant abnormal laboratory values. AEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment. Only patients who received study treatments were assessed for safety. All patients in the ITT population were assessed for all-cause mortality. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.