Trial Outcomes & Findings for Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867) (NCT NCT03924869)

NCT ID: NCT03924869

Last Updated: 2025-12-11

Results Overview

EFS was defined as the time from randomization to the first occurrence of any of the following events: 1) local, regional, or distant recurrence of disease as assessed by radiographic recurrence by blinded independent central review (BICR), positive pathology by local assessment, physical examination by local assessment confirmed by positive pathology and/or radiographic recurrence by BICR, OR 2) death due to any cause. EFS was reported for each arm.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 448 participants
• Primary outcome timeframe: Up to approximately 56.8 months
• Results posted on: 2025-12-11

Participant Flow

Male and female participants at least 18 years of age with unresected Stage I or II (limited Stage IIB N0, M0) Non-Small Cell Lung Cancer (NSCLC) who had received no prior anticancer therapy for their present lung cancer were recruited.

Of 737 participants screened, 448 were randomized 1:1 to receive either stereotactic body radiotherapy (SBRT) plus pembrolizumab or SBRT plus placebo.

Participant milestones

Measure	SBRT + Pembrolizumab Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Overall Study STARTED	227	221
Overall Study Treated	226	218
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	227	221

Reasons for withdrawal

Measure	SBRT + Pembrolizumab Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Overall Study Death	73	62
Overall Study Lost to Follow-up	3	0
Overall Study Physician Decision	0	3
Overall Study Withdrawal by Subject	7	3
Overall Study Study Terminated By Sponsor	144	153

Baseline Characteristics

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

Baseline characteristics by cohort

Measure	SBRT + Pembrolizumab n=227 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=221 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	Total n=448 Participants Total of all reporting groups
Age, Continuous	73.2 years STANDARD_DEVIATION 8.0 • n=237 Participants	72.4 years STANDARD_DEVIATION 7.6 • n=243 Participants	72.8 years STANDARD_DEVIATION 7.8 • n=480 Participants
Sex: Female, Male Female	89 Participants n=237 Participants	100 Participants n=243 Participants	189 Participants n=480 Participants
Sex: Female, Male Male	138 Participants n=237 Participants	121 Participants n=243 Participants	259 Participants n=480 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=237 Participants	20 Participants n=243 Participants	43 Participants n=480 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	190 Participants n=237 Participants	186 Participants n=243 Participants	376 Participants n=480 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=237 Participants	15 Participants n=243 Participants	29 Participants n=480 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=237 Participants	1 Participants n=243 Participants	1 Participants n=480 Participants
Race (NIH/OMB) Asian	31 Participants n=237 Participants	26 Participants n=243 Participants	57 Participants n=480 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Black or African American	4 Participants n=237 Participants	6 Participants n=243 Participants	10 Participants n=480 Participants
Race (NIH/OMB) White	183 Participants n=237 Participants	177 Participants n=243 Participants	360 Participants n=480 Participants
Race (NIH/OMB) More than one race	0 Participants n=237 Participants	2 Participants n=243 Participants	2 Participants n=480 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=237 Participants	9 Participants n=243 Participants	18 Participants n=480 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score ECOG PS 0 = Normal activity	86 Participants n=237 Participants	84 Participants n=243 Participants	170 Participants n=480 Participants
NSCLC Disease Stage Stage I	204 Participants n=237 Participants	197 Participants n=243 Participants	401 Participants n=480 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score ECOG PS 1 = Symptoms, but ambulatory	122 Participants n=237 Participants	122 Participants n=243 Participants	244 Participants n=480 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score ECOG PS 2 = Ambulatory, capable of selfcare, unable to carry out work activities	19 Participants n=237 Participants	15 Participants n=243 Participants	34 Participants n=480 Participants
NSCLC Disease Stage Stage II	23 Participants n=237 Participants	24 Participants n=243 Participants	47 Participants n=480 Participants
Geographic Region of Enrollment Site East Asia	29 Participants n=237 Participants	26 Participants n=243 Participants	55 Participants n=480 Participants
Geographic Region of Enrollment Site Non-East Asia	198 Participants n=237 Participants	195 Participants n=243 Participants	393 Participants n=480 Participants
Reason for not Receiving Surgery Refused Surgery	43 Participants n=237 Participants	36 Participants n=243 Participants	79 Participants n=480 Participants
Reason for not Receiving Surgery Medically Inoperable	184 Participants n=237 Participants	185 Participants n=243 Participants	369 Participants n=480 Participants

PRIMARY outcome

Timeframe: Up to approximately 56.8 months

Population: All randomized participants were analyzed according to the treatment arm they were randomized to.

EFS was defined as the time from randomization to the first occurrence of any of the following events: 1) local, regional, or distant recurrence of disease as assessed by radiographic recurrence by blinded independent central review (BICR), positive pathology by local assessment, physical examination by local assessment confirmed by positive pathology and/or radiographic recurrence by BICR, OR 2) death due to any cause. EFS was reported for each arm.

Outcome measures

Measure	SBRT + Pembrolizumab n=227 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=221 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Event-free Survival (EFS)	31.2 months Interval 22.5 to 39.1	28.3 months Interval 19.8 to 33.1

SECONDARY outcome

Timeframe: Up to approximately 56.8 months

Population: All randomized participants were analyzed according to the treatment arm they were randomized to.

OS was defined as the time from date of randomization to date of death from any cause. OS was reported for each arm.

Outcome measures

Measure	SBRT + Pembrolizumab n=227 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=221 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Overall Survival (OS)	54.7 months Interval 33.5 to NA = Kaplan-Meier estimate for OS upper 95% confidence limit was not reached at time of data cut-off due to an insufficient number of participants with an event.	NA months Interval 44.4 to NA = Kaplan-Meier estimates for median OS and OS upper 95% confidence limit were not reached at time of data cut-off due to an insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 56.8 months

Population: All randomized participants were analyzed according to the treatment arm they were randomized to.

TTDM was defined as the time from randomization to the first documented distant metastases or death from any cause, whichever occurred first. The TDDM was reported for each arm.

Outcome measures

Measure	SBRT + Pembrolizumab n=227 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=221 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Time to Death or Distant Metastases (TDDM)	39.1 months Interval 30.5 to NA = Kaplan-Meier estimate for TDDM upper 95% confidence limit was not reached at time of data cut-off due to an insufficient number of participants with an event.	41.3 months Interval 31.1 to NA = Kaplan-Meier estimate for TDDM upper 95% confidence limit was not reached at time of data cut-off due to an insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 64 months

Population: The analysis population consisted of all participants who received at least 1 dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE were reported.

Outcome measures

Measure	SBRT + Pembrolizumab n=226 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=218 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Number of Participants Who Experienced an Adverse Event (AE)	217 Participants	200 Participants

SECONDARY outcome

Timeframe: Up to approximately 16 months

Population: The analysis population consisted of all participants who received at least 1 dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported.

Outcome measures

Measure	SBRT + Pembrolizumab n=226 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=218 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)	62 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-C30 assessment available were analyzed.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.

Outcome measures

Measure	SBRT + Pembrolizumab n=225 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=214 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score	-2.17 Score on a Scale Interval -5.0 to 0.66	-0.96 Score on a Scale Interval -3.78 to 1.86

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-LC13 assessment available were analyzed.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the EORTC QLQ-LC13 question "How much did you cough?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in cough (EORTC QLQ LC13 Item 31) score was reported for each arm.

Outcome measures

Measure	SBRT + Pembrolizumab n=225 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=214 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Cough (Item 31) Score	-1.44 Score on a scale Interval -5.23 to 2.36	2.91 Score on a scale Interval -0.87 to 6.68

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-LC13 assessment available were analyzed.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score was reported for each arm.

Outcome measures

Measure	SBRT + Pembrolizumab n=225 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=214 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Chest Pain (Item 40) Score	3.00 Score on a Scale Interval -0.09 to 6.1	1.76 Score on a Scale Interval -1.32 to 4.84

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-C30 assessment available were analyzed.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score was reported for each arm.

Outcome measures

Measure	SBRT + Pembrolizumab n=225 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=214 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score	-1.80 Score on a Scale Interval -5.95 to 2.36	-0.81 Score on a Scale Interval -4.94 to 3.32

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-C30 assessment available were analyzed.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score was reported for each arm.

Outcome measures

Measure	SBRT + Pembrolizumab n=225 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	SBRT + Placebo n=214 Participants Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score	-0.52 Score on a Scale Interval -3.08 to 2.03	-0.31 Score on a Scale Interval -2.86 to 2.24

Adverse Events

Pembrolizumab + SBRT

Serious events: 90 serious events

Other events: 198 other events

Deaths: 76 deaths

Placebo + SBRT

Serious events: 74 serious events

Other events: 176 other events

Deaths: 63 deaths

Serious adverse events

Measure	Pembrolizumab + SBRT n=226 participants at risk Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	Placebo + SBRT n=218 participants at risk Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Blood and lymphatic system disorders Anaemia	1.8% 4/226 • Number of events 4 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Aplasia pure red cell	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Angina pectoris	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Angina unstable	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Atrial fibrillation	1.8% 4/226 • Number of events 4 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Cardiac arrest	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.92% 2/218 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Cardiac failure	1.3% 3/226 • Number of events 3 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.92% 2/218 • Number of events 3 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Cardiac failure chronic	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Cardiac failure congestive	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Dilated cardiomyopathy	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Myocardial ischaemia	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Myocarditis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Pericardial effusion	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Ear and labyrinth disorders Vertigo	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Adrenal insufficiency	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Immune-mediated hyperthyroidism	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Colitis	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Constipation	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Diarrhoea	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.92% 2/218 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Gastric haemorrhage	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Gastric ischaemia	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Immune-mediated enterocolitis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Intestinal obstruction	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Nausea	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Oesophagitis	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Pancreatitis acute	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Vomiting	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Asthenia	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Chest pain	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Death	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Drowning	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders General physical health deterioration	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Non-cardiac chest pain	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Pyrexia	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Bile duct stenosis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Cholecystitis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Hepatitis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Immune-mediated hepatitis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Immune system disorders Cytokine release syndrome	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Abscess oral	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Bronchiolitis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations COVID-19	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	2.3% 5/218 • Number of events 5 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations COVID-19 pneumonia	1.3% 3/226 • Number of events 3 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	2.8% 6/218 • Number of events 6 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Catheter site infection	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Cellulitis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Conjunctivitis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Erysipelas	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Lower respiratory tract infection	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Periodontitis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumonia	8.4% 19/226 • Number of events 23 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.2% 7/218 • Number of events 7 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumonia aspiration	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumonia bacterial	2.7% 6/226 • Number of events 6 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.92% 2/218 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Prostate infection	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pyelonephritis	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Respiratory tract infection	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Sepsis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Urinary tract infection	2.7% 6/226 • Number of events 7 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Anastomotic stenosis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Fall	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Hand fracture	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Radiation pneumonitis	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Alanine aminotransferase increased	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Aspartate aminotransferase increased	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Gamma-glutamyltransferase increased	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Intraocular pressure increased	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations SARS-CoV-2 test positive	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Diabetes mellitus	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Myalgia	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.92% 2/218 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer recurrent	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.92% 2/218 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Cerebral infarction	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Cerebrovascular accident	1.3% 3/226 • Number of events 4 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.92% 2/218 • Number of events 3 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Encephalitis autoimmune	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Epilepsy	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Headache	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Hydrocephalus	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Migraine	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Parkinson's disease	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Parkinsonism	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Presyncope	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Seizure	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Transient ischaemic attack	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Delirium	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Depression	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Disorientation	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Insomnia	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Mania	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Acute kidney injury	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Renal failure	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.92% 2/218 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Renal impairment	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Urinary tract obstruction	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Aspiration	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	7.1% 16/226 • Number of events 24 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	4.6% 10/218 • Number of events 12 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 3/226 • Number of events 3 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.4% 3/218 • Number of events 3 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.1% 7/226 • Number of events 7 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Aortic aneurysm rupture	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Embolism	0.44% 1/226 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/218 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Hypertension	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Hypotension	0.00% 0/226 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Peripheral arterial occlusive disease	0.88% 2/226 • Number of events 2 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.46% 1/218 • Number of events 1 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.

Other adverse events

Measure	Pembrolizumab + SBRT n=226 participants at risk Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \[Gy\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.	Placebo + SBRT n=218 participants at risk Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.
Blood and lymphatic system disorders Anaemia	12.4% 28/226 • Number of events 32 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.9% 15/218 • Number of events 18 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Hyperthyroidism	5.8% 13/226 • Number of events 13 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	2.3% 5/218 • Number of events 5 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Hypothyroidism	16.4% 37/226 • Number of events 41 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	4.6% 10/218 • Number of events 10 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Constipation	8.8% 20/226 • Number of events 23 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	9.6% 21/218 • Number of events 23 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Diarrhoea	16.8% 38/226 • Number of events 52 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	14.2% 31/218 • Number of events 43 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Nausea	7.5% 17/226 • Number of events 22 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	11.5% 25/218 • Number of events 30 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Vomiting	8.0% 18/226 • Number of events 20 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.7% 8/218 • Number of events 11 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Asthenia	8.8% 20/226 • Number of events 22 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.3% 18/218 • Number of events 22 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Chest pain	6.6% 15/226 • Number of events 18 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 16/218 • Number of events 22 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Fatigue	22.6% 51/226 • Number of events 61 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	19.7% 43/218 • Number of events 48 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Oedema peripheral	5.3% 12/226 • Number of events 12 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.9% 15/218 • Number of events 17 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Pyrexia	6.2% 14/226 • Number of events 17 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	2.3% 5/218 • Number of events 5 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations COVID-19	5.3% 12/226 • Number of events 12 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 16/218 • Number of events 18 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumonia	5.3% 12/226 • Number of events 14 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	4.6% 10/218 • Number of events 12 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Urinary tract infection	4.9% 11/226 • Number of events 16 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 16/218 • Number of events 20 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Radiation pneumonitis	8.8% 20/226 • Number of events 22 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.7% 19/218 • Number of events 20 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Alanine aminotransferase increased	7.5% 17/226 • Number of events 23 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	4.6% 10/218 • Number of events 12 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Aspartate aminotransferase increased	6.6% 15/226 • Number of events 18 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	4.6% 10/218 • Number of events 11 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Blood creatinine increased	8.8% 20/226 • Number of events 28 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	9.2% 20/218 • Number of events 25 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	11.5% 26/226 • Number of events 27 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 16/218 • Number of events 16 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	8.0% 18/226 • Number of events 24 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.7% 8/218 • Number of events 9 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	5.3% 12/226 • Number of events 13 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.7% 8/218 • Number of events 11 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	17.7% 40/226 • Number of events 49 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 16/218 • Number of events 17 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	7.5% 17/226 • Number of events 17 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.3% 18/218 • Number of events 19 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	5.8% 13/226 • Number of events 17 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.0% 13/218 • Number of events 14 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Dizziness	6.2% 14/226 • Number of events 14 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.0% 13/218 • Number of events 14 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Headache	5.8% 13/226 • Number of events 15 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.7% 19/218 • Number of events 22 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Insomnia	7.1% 16/226 • Number of events 16 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.0% 13/218 • Number of events 13 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	7.1% 16/226 • Number of events 20 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	4.6% 10/218 • Number of events 12 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	15.0% 34/226 • Number of events 39 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	17.9% 39/218 • Number of events 46 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.1% 41/226 • Number of events 47 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	17.9% 39/218 • Number of events 42 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.0% 18/226 • Number of events 18 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.8% 4/218 • Number of events 4 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	6.6% 15/226 • Number of events 19 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.2% 7/218 • Number of events 9 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Dry skin	4.4% 10/226 • Number of events 10 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.0% 13/218 • Number of events 14 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	17.3% 39/226 • Number of events 44 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	9.6% 21/218 • Number of events 35 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Rash	15.9% 36/226 • Number of events 53 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 16/218 • Number of events 20 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Hypertension	5.8% 13/226 • Number of events 15 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	5.5% 12/218 • Number of events 12 • Up to approximately 64 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor will comply with the requirements for publication of study results, and will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
• Publication restrictions are in place

Restriction type: OTHER