Trial Outcomes & Findings for A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma (NCT NCT03698019)

NCT ID: NCT03698019

Last Updated: 2025-12-05

Results Overview

Event-free survival (EFS) is measured from date of randomization to date of first: documentation of progression that render participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, failure to begin adjuvant therapy within 84 days after surgery, relapse after surgery or death due to any cause. Participants last known to be alive and event-free are censored at date of last contact. All events that occurred before the start of adjuvant therapy were assigned an event date of 84 days.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 313 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2025-12-05

Participant Flow

Three hundred forty-five participants were assessed for eligibility. Thirty-two participants were deemed ineligible for either not having measurable disease, per RECIST criteria (27 participants), or having an ineligible disease stage (5). The remaining 313 eligible participants were randomized.

Participant milestones

Measure	Arm I (Adjuvant Pembrolizumab) Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Step 1: Registration STARTED	159	154
Step 1: Registration COMPLETED	151	127
Step 1: Registration NOT COMPLETED	8	27
Step 2: Surgery STARTED	151	127
Step 2: Surgery COMPLETED	130	109
Step 2: Surgery NOT COMPLETED	21	18
Step 3: Adjuvant Pembrolizumab STARTED	130	109
Step 3: Adjuvant Pembrolizumab COMPLETED	38	50
Step 3: Adjuvant Pembrolizumab NOT COMPLETED	92	59

Reasons for withdrawal

Measure	Arm I (Adjuvant Pembrolizumab) Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Step 1: Registration Still receiving protocol therapy	0	10
Step 1: Registration Withdrawal by Subject	7	2
Step 1: Registration Toxicity	0	1
Step 1: Registration Disease Progression	0	12
Step 1: Registration Co-morbidities	0	1
Step 1: Registration Scheduling Issues	1	0
Step 1: Registration Participant Refusal	0	1
Step 2: Surgery Participant Refusal	2	1
Step 2: Surgery Neoadjuvant Toxicity	0	3
Step 2: Surgery Metastatic Disease	16	9
Step 2: Surgery Residual Disease	2	1
Step 2: Surgery Trial Closed due to Covid-19	0	1
Step 2: Surgery Concerns about Exposure to Covid-19	0	1
Step 2: Surgery Disease other than melanoma identified at surgery	0	2
Step 2: Surgery Radiotherapy-related Delays	1	0
Step 3: Adjuvant Pembrolizumab Still receiving protocol therapy	41	33
Step 3: Adjuvant Pembrolizumab Disease Progression	41	9
Step 3: Adjuvant Pembrolizumab Death	4	1
Step 3: Adjuvant Pembrolizumab Other, unspecified reasons	6	16

Baseline Characteristics

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma

Baseline characteristics by cohort

Measure	Arm I (Adjuvant Pembrolizumab) n=159 Participants Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) n=154 Participants Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Total n=313 Participants Total of all reporting groups
Age, Continuous	62 years n=37 Participants	64 years n=37 Participants	64 years n=74 Participants
Sex: Female, Male Female	48 Participants n=37 Participants	62 Participants n=37 Participants	110 Participants n=74 Participants
Sex: Female, Male Male	111 Participants n=37 Participants	92 Participants n=37 Participants	203 Participants n=74 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=37 Participants	9 Participants n=37 Participants	13 Participants n=74 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	151 Participants n=37 Participants	136 Participants n=37 Participants	287 Participants n=74 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=37 Participants	9 Participants n=37 Participants	13 Participants n=74 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Asian	2 Participants n=37 Participants	2 Participants n=37 Participants	4 Participants n=74 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Black or African American	2 Participants n=37 Participants	1 Participants n=37 Participants	3 Participants n=74 Participants
Race (NIH/OMB) White	150 Participants n=37 Participants	141 Participants n=37 Participants	291 Participants n=74 Participants
Race (NIH/OMB) More than one race	1 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=37 Participants	10 Participants n=37 Participants	14 Participants n=74 Participants
Zubrod Performance Status Score 0	125 Participants n=37 Participants	113 Participants n=37 Participants	238 Participants n=74 Participants
Zubrod Performance Status Score 1	33 Participants n=37 Participants	39 Participants n=37 Participants	72 Participants n=74 Participants
Zubrod Performance Status Score 2	0 Participants n=37 Participants	1 Participants n=37 Participants	1 Participants n=74 Participants
Zubrod Performance Status Score Missing/Not Reported	1 Participants n=37 Participants	1 Participants n=37 Participants	2 Participants n=74 Participants
LDH Level Low or Normal	138 Participants n=37 Participants	132 Participants n=37 Participants	270 Participants n=74 Participants
LDH Level High	21 Participants n=37 Participants	22 Participants n=37 Participants	43 Participants n=74 Participants
Disease Stage IIIB	64 Participants n=37 Participants	62 Participants n=37 Participants	126 Participants n=74 Participants
Disease Stage IIIC	74 Participants n=37 Participants	69 Participants n=37 Participants	143 Participants n=74 Participants
Disease Stage IIID	10 Participants n=37 Participants	9 Participants n=37 Participants	19 Participants n=74 Participants
Disease Stage IV	11 Participants n=37 Participants	14 Participants n=37 Participants	25 Participants n=74 Participants
Primary Melanoma Subtype Cutaneous or Unknown	153 Participants n=37 Participants	143 Participants n=37 Participants	296 Participants n=74 Participants
Primary Melanoma Subtype Acral	5 Participants n=37 Participants	4 Participants n=37 Participants	9 Participants n=74 Participants
Primary Melanoma Subtype Mucosal	0 Participants n=37 Participants	4 Participants n=37 Participants	4 Participants n=74 Participants
Primary Melanoma Subtype Missing/Not Reported	1 Participants n=37 Participants	3 Participants n=37 Participants	4 Participants n=74 Participants
Ulceration Yes	46 Participants n=37 Participants	56 Participants n=37 Participants	102 Participants n=74 Participants
Ulceration No	58 Participants n=37 Participants	50 Participants n=37 Participants	108 Participants n=74 Participants
Ulceration Unknown	55 Participants n=37 Participants	46 Participants n=37 Participants	101 Participants n=74 Participants
Ulceration Missing/Not Reported	0 Participants n=37 Participants	2 Participants n=37 Participants	2 Participants n=74 Participants
BRAF Mutation Status Mutated	38 Participants n=37 Participants	41 Participants n=37 Participants	79 Participants n=74 Participants
BRAF Mutation Status Wild-type	64 Participants n=37 Participants	62 Participants n=37 Participants	126 Participants n=74 Participants
BRAF Mutation Status Unknown	57 Participants n=37 Participants	51 Participants n=37 Participants	108 Participants n=74 Participants
Previous BRAF and MEK Adjuvant Therapy Yes	1 Participants n=37 Participants	3 Participants n=37 Participants	4 Participants n=74 Participants
Previous BRAF and MEK Adjuvant Therapy No	158 Participants n=37 Participants	151 Participants n=37 Participants	309 Participants n=74 Participants
Previous Radiotherapy Yes	1 Participants n=37 Participants	2 Participants n=37 Participants	3 Participants n=74 Participants
Previous Radiotherapy No	158 Participants n=37 Participants	152 Participants n=37 Participants	310 Participants n=74 Participants

PRIMARY outcome

Timeframe: 2 years

Event-free survival (EFS) is measured from date of randomization to date of first: documentation of progression that render participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, failure to begin adjuvant therapy within 84 days after surgery, relapse after surgery or death due to any cause. Participants last known to be alive and event-free are censored at date of last contact. All events that occurred before the start of adjuvant therapy were assigned an event date of 84 days.

Outcome measures

Measure	Arm I (Adjuvant Pembrolizumab) n=159 Participants Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) n=154 Participants Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Two-Year Event-Free Survival Rate	49 percentage of participants Interval 41.0 to 59.0	72 percentage of participants Interval 64.0 to 80.0

SECONDARY outcome

Timeframe: Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.

Population: Eligible participants that received protocol treatment

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Measure	Arm I (Adjuvant Pembrolizumab) n=141 Participants Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) n=152 Participants Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hepatobiliary disorders - Other, specify	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hyperglycemia	3 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hypertension	2 Participants	3 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hypokalemia	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hyponatremia	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hypothyroidism	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Infections and infestations - Other, specify	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Lung infection	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Lymphocyte count decreased	3 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Metabolism and nutrition disorders - Other, specif	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Myalgia	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Myocarditis	1 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Myositis	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Nausea	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Neutrophil count decreased	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Platelet count decreased	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pneumonitis	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pruritus	2 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash maculo-papular	4 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Respiratory failure	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Sepsis	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Seroma	1 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Skin and subcutaneous tissue disorders - Other, sp	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Skin infection	1 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Small intestinal obstruction	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Soft tissue infection	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Stroke	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Surgical and medical procedures - Other, specify	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Syncope	1 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Thromboembolic event	1 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Urinary tract infection	1 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Vomiting	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug White blood cell decreased	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Wound dehiscence	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Wound infection	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Gallbladder infection	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Headache	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hematoma	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Chest wall pain	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Cognitive disturbance	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Colitis	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dehydration	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Diarrhea	1 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Electrocardiogram QT corrected interval prolonged	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fall	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fatigue	2 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Febrile neutropenia	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fever	0 Participants	2 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Adrenal insufficiency	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Alanine aminotransferase increased	3 Participants	5 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Alkaline phosphatase increased	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Anemia	0 Participants	1 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Arthralgia	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Arthritis	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Aspartate aminotransferase increased	2 Participants	4 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Blood and lymphatic system disorders - Other, spec	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Cardiac disorders - Other, specify	1 Participants	0 Participants
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Cardiac troponin I increased	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 years

Overall survival (OS) is measured from date of randomization to date of death due to any cause. Participants known to be alive are censored at date of last contact.

Outcome measures

Measure	Arm I (Adjuvant Pembrolizumab) n=159 Participants Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) n=154 Participants Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Two-Year Overall Survival Rate	79 percentage of participants Interval 71.0 to 89.0	87 percentage of participants Interval 80.0 to 95.0

SECONDARY outcome

Timeframe: 2 years

On the neoadjuvant arm, the response rate was assessed after neoadjuvant therapy and before surgical resection. The response rate includes both complete response (CR) and partial response (PR). CR is defined as complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. PR is defined as greater than or equal to 30% decrease under baseline of the sum of all appropriate diameters of all target measurable lesions, no unequivocal progression or non-measurable disease, and no new lesions. The best response rate is calculated from the sequence of objective statuses. CR is defined as two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. PR is defined as two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 years

To determine the number of participants on each arm who received the surgery planned at randomization.

Outcome measures

Measure	Arm I (Adjuvant Pembrolizumab) n=159 Participants Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) n=154 Participants Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Number of Participants Receiving Surgery	151 Participants	127 Participants

Adverse Events

Arm I (Adjuvant Pembrolizumab)

Serious events: 33 serious events

Other events: 132 other events

Deaths: 22 deaths

Arm II (Adjuvant and Neoadjuvant Pembrolizumab)

Serious events: 34 serious events

Other events: 148 other events

Deaths: 14 deaths

Serious adverse events

Measure	Arm I (Adjuvant Pembrolizumab) n=141 participants at risk Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) n=152 participants at risk Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Blood and lymphatic system disorders Anemia	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Cardiac disorders Cardiac disorders-Other	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Cardiac disorders Chest pain - cardiac	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Cardiac disorders Myocarditis	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Endocrine disorders Adrenal insufficiency	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Endocrine disorders Endocrine disorders-Other	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Endocrine disorders Hypothyroidism	1.4% 2/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Abdominal pain	1.4% 2/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Colitis	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Diarrhea	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	2.0% 3/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Nausea	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	2.0% 3/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Pancreatitis	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Vomiting	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	2.0% 3/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Edema limbs	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Fatigue	2.1% 3/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Fever	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.3% 8/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Flu like symptoms	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders General disorders and administration site conditio	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Hypothermia	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Hepatobiliary disorders Cholecystitis	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Hepatobiliary disorders Hepatobiliary disorders-Other	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Gallbladder infection	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Lung infection	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	2.0% 3/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Sepsis	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Skin infection	2.1% 3/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Soft tissue infection	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Urinary tract infection	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Wound infection	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Injury, poisoning and procedural complications Fall	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Injury, poisoning and procedural complications Fracture	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications-Oth	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Injury, poisoning and procedural complications Seroma	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Alanine aminotransferase increased	2.1% 3/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	2.6% 4/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Alkaline phosphatase increased	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Aspartate aminotransferase increased	1.4% 2/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	3.3% 5/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Creatinine increased	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Neutrophil count decreased	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Platelet count decreased	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Weight loss	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations White blood cell decreased	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Dehydration	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hyperglycemia	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hypoglycemia	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Metabolism and nutrition disorders-Other	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Arthritis	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Flank pain	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Myositis	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Cognitive disturbance	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Facial muscle weakness	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Headache	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Intracranial hemorrhage	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Stroke	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Syncope	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Transient ischemic attacks	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Vasovagal reaction	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal conditions-Oth	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Psychiatric disorders Personality change	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.4% 2/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Pruritus	1.4% 2/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.4% 2/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Vascular disorders Hematoma	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	1.3% 2/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Vascular disorders Hypertension	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Vascular disorders Lymph leakage	0.00% 0/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.66% 1/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Vascular disorders Thromboembolic event	0.71% 1/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	0.00% 0/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.

Other adverse events

Measure	Arm I (Adjuvant Pembrolizumab) n=141 participants at risk Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Arm II (Adjuvant and Neoadjuvant Pembrolizumab) n=152 participants at risk Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Endocrine disorders Hyperthyroidism	7.8% 11/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	3.9% 6/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Endocrine disorders Hypothyroidism	18.4% 26/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	17.1% 26/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Blood and lymphatic system disorders Anemia	26.2% 37/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	35.5% 54/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Blood and lymphatic system disorders Blood and lymphatic system disorders-Other	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	6.6% 10/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Blood and lymphatic system disorders Eosinophilia	7.1% 10/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	3.9% 6/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Eye disorders Blurred vision	4.3% 6/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	6.6% 10/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Eye disorders Eye disorders-Other	5.0% 7/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	6.6% 10/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Abdominal pain	6.4% 9/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	9.2% 14/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Constipation	13.5% 19/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	14.5% 22/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Diarrhea	24.1% 34/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	25.7% 39/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Dry mouth	10.6% 15/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	4.6% 7/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Gastrointestinal disorders-Other	4.3% 6/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	7.2% 11/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Nausea	23.4% 33/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	26.3% 40/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Gastrointestinal disorders Vomiting	9.2% 13/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	11.8% 18/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Chills	9.2% 13/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	7.2% 11/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Edema limbs	23.4% 33/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	25.7% 39/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Fatigue	63.8% 90/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	59.2% 90/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Fever	7.1% 10/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	6.6% 10/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
General disorders Pain	23.4% 33/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	21.7% 33/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Infections and infestations-Other	12.1% 17/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	8.6% 13/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Skin infection	10.6% 15/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	9.9% 15/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Upper respiratory infection	2.1% 3/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.3% 8/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Infections and infestations Urinary tract infection	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	3.3% 5/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Injury, poisoning and procedural complications Seroma	7.8% 11/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	4.6% 7/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Alanine aminotransferase increased	12.1% 17/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	17.8% 27/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Alkaline phosphatase increased	9.2% 13/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	13.8% 21/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Aspartate aminotransferase increased	12.1% 17/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	19.1% 29/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Blood bilirubin increased	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	8.6% 13/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Creatinine increased	12.1% 17/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	18.4% 28/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Investigations-Other	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	3.3% 5/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Lymphocyte count decreased	13.5% 19/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	19.7% 30/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Platelet count decreased	6.4% 9/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	8.6% 13/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Thyroid stimulating hormone increased	7.1% 10/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	10.5% 16/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations Weight loss	12.8% 18/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	8.6% 13/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Investigations White blood cell decreased	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	7.2% 11/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Anorexia	10.6% 15/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	17.8% 27/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hypercalcemia	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.9% 9/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hyperglycemia	32.6% 46/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	31.6% 48/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hyperkalemia	4.3% 6/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	8.6% 13/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hypoalbuminemia	8.5% 12/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	12.5% 19/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hypocalcemia	12.8% 18/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.9% 9/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hypoglycemia	4.3% 6/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.3% 8/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hypokalemia	6.4% 9/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	11.8% 18/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Metabolism and nutrition disorders Hyponatremia	16.3% 23/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	14.5% 22/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Arthralgia	18.4% 26/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	19.1% 29/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Arthritis	4.3% 6/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.3% 8/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Back pain	12.1% 17/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	8.6% 13/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Myalgia	13.5% 19/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	11.2% 17/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 10/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.9% 9/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	18.4% 26/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	19.1% 29/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Dizziness	9.2% 13/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	9.2% 14/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Dysgeusia	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	3.9% 6/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Headache	16.3% 23/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	19.1% 29/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Paresthesia	14.2% 20/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	11.8% 18/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Nervous system disorders Peripheral sensory neuropathy	6.4% 9/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.9% 9/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Psychiatric disorders Anxiety	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	10.5% 16/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Psychiatric disorders Insomnia	9.2% 13/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	8.6% 13/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Renal and urinary disorders Urinary frequency	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	4.6% 7/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Cough	24.1% 34/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	19.7% 30/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.3% 23/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	13.2% 20/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.1% 10/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	4.6% 7/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.5% 5/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.3% 8/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Dry skin	9.9% 14/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	7.9% 12/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Pruritus	25.5% 36/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	28.3% 43/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Rash acneiform	6.4% 9/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	6.6% 10/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	29.8% 42/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	28.9% 44/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders-Other	18.4% 26/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	16.4% 25/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Skin and subcutaneous tissue disorders Skin hypopigmentation	5.7% 8/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	7.9% 12/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Surgical and medical procedures Surgical and medical procedures-Other	1.4% 2/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	5.3% 8/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Vascular disorders Hypertension	28.4% 40/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	28.9% 44/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
Vascular disorders Lymphedema	10.6% 15/141 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.	14.5% 22/152 • Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.

Additional Information

Melanoma Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: jmoon@fredhutch.org

Results disclosure agreements

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

Restriction type: LTE60