Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087) (NCT NCT02453594)

Last Updated: 2024-10-29

Results Overview

ORR is the percentage of participants who had a complete response (CR) or partial response (PR) prior to disease progression based on the International Working Group (IWG) criteria using blinded independent central review (BICR). CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. It is hypothesized that ORR will be greater than 20% in each of the 3 cohorts.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

211 participants

Primary outcome timeframe

Up to approximately 99 months

Results posted on

2024-10-29

Participant Flow

Males and females with relapsed or refractory de novo classical Hodgkin lymphoma (RRcHL) of at least 18 years of age were enrolled in this study.

Participant milestones

Participant milestones
Measure	Cohort 1 Participants with RRcHL who failed to achieve a response or progressed after auto-stem cell transplant (SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Overall Study STARTED	69	81	61
Overall Study Treated	69	81	60
Overall Study Second Course Pembrolizumab	10	7	3
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	69	81	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Participants with RRcHL who failed to achieve a response or progressed after auto-stem cell transplant (SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Overall Study Protocol Violation	0	0	1
Overall Study Cohort Was Closed	17	21	14
Overall Study Death	20	24	16
Overall Study Lost to Follow-up	6	14	2
Overall Study Physician Decision	2	4	0
Overall Study Site Terminated by Sponsor	1	0	1
Overall Study Transitioned to Extension Study	16	9	16
Overall Study Withdrawal by Subject	7	9	11

Baseline Characteristics

Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.	Total n=210 Participants Total of all reporting groups
Age, Continuous	37.0 Years STANDARD_DEVIATION 10.9 • n=5 Participants	42.3 Years STANDARD_DEVIATION 17.4 • n=7 Participants	36.8 Years STANDARD_DEVIATION 13.4 • n=5 Participants	39.0 Years STANDARD_DEVIATION 14.5 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	38 Participants n=7 Participants	26 Participants n=5 Participants	97 Participants n=4 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	43 Participants n=7 Participants	34 Participants n=5 Participants	113 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	63 Participants n=7 Participants	48 Participants n=5 Participants	154 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	41 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	73 Participants n=7 Participants	55 Participants n=5 Participants	185 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Overall Response Rate (ORR) by BICR Based on IWG Criteria	78.3 Percentage of participants Interval 66.7 to 87.3	64.2 Percentage of participants Interval 52.8 to 74.6	73.3 Percentage of participants Interval 60.3 to 83.9

PRIMARY outcome

Timeframe: Up to 27 months

Population: All allocated participants who received at least 1 dose of study treatment.

An adverse event (AE) is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Percentage of Participants Experiencing at Least One Adverse Event (AE)	98.6 Percentage of Participants	98.8 Percentage of Participants	95.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: All allocated participants who received at least 1 dose of study treatment

An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Percentage of Participants Discontinuing Study Drug Due to AEs	11.6 Percentage of Participants	6.2 Percentage of Participants	8.3 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

ORR is the percentage of participants who had a CR or PR prior to disease progression based on the Lugano criteria using BICR. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Overall Response Rate (ORR) by BICR Based on Lugano Criteria	82.6 Percentage of participants Interval 71.6 to 90.7	67.9 Percentage of participants Interval 56.6 to 77.8	68.3 Percentage of participants Interval 55.0 to 79.7

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

ORR is the percentage of participants who had a CR or PR prior to disease progression assessed by the investigator using IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria	72.5 Percentage of participants Interval 60.4 to 82.5	66.7 Percentage of participants Interval 55.3 to 76.8	71.7 Percentage of participants Interval 58.6 to 82.5

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the IWG criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Complete Remission Rate (CRR) by BICR Based on IWG Criteria	24.6 Percentage of participants	25.9 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the Lugano criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Complete Remission Rate (CRR) by BICR Based on Lugano Criteria	34.8 Percentage of participants	28.4 Percentage of participants	35.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes assessed by the investigator using IWG criteria. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria	42.0 Percentage of participants	32.1 Percentage of participants	43.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first based on BICR. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Progression-free Survival (PFS) Based on BICR	16.5 Months Interval 12.0 to 30.3	11.1 Months Interval 7.5 to 13.7	19.7 Months Interval 10.8 to 32.9

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by the investigator based on the IWG criteria. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Progression-free Survival (PFS) Assessed by the Investigator	24.9 Months Interval 13.9 to 33.9	13.9 Months Interval 10.9 to 22.4	22.0 Months Interval 11.1 to 30.3

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment and had a CR or PR response.

DOR for the subgroup of participants who achieved a CR or PR by independent central review, is the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first based on BICR. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The analysis used the Kaplan-Meier method, with participants with response censored at their last assessment, and there was no progressive disease at the time of the last disease assessment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=54 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=52 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=44 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Duration of Response (DOR) Based on BICR	25.0 Months Interval 0.0 to 88.8	11.1 Months Interval 0.0 to 86.2	24.4 Months Interval 0.0 to 88.3

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment and had a CR or PR response.

DOR for the subgroup of participants who achieved a CR or PR by independent central review, is the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first assessed by the investigator based on the IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The analysis used the Kaplan-Meier method, with participants with response censored at their last assessment, and there was no progressive disease at the time of the last disease assessment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=50 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=54 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=43 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Duration of Response (DOR) Assessed by the Investigator	25.0 Months Interval 0.0 to 88.8	16.4 Months Interval 0.0 to 86.1	24.7 Months Interval 2.8 to 91.2

SECONDARY outcome

Timeframe: Up to approximately 99 months

Population: All allocated participants who received at least 1 dose of study treatment.

OS is the time from the first dose to death due to any cause. The Kaplan-Meier method was used to estimate the survival curve, separately by Cohort with missing data censored at last assessment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=69 Participants Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 n=81 Participants Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 n=60 Participants Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
Overall Survival (OS)	NA Months NA means median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA means median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA means median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.

Adverse Events

Cohort 1 (First Course)

Serious events: 15 serious events

Other events: 68 other events

Deaths: 21 deaths

Cohort 2 (First Course)

Serious events: 18 serious events

Other events: 76 other events

Deaths: 28 deaths

Cohort 3 (First Course)

Serious events: 15 serious events

Other events: 56 other events

Deaths: 19 deaths

Cohort 1 (Second Course)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 2 deaths

Cohort 2 (Second Course)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 3 (Second Course)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 (First Course) n=69 participants at risk Participants with RRcHL who failed to achieve a response or progressed after auto-stem cell transplant (SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 (First Course) n=81 participants at risk Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 (First Course) n=60 participants at risk Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.	Cohort 1 (Second Course) n=10 participants at risk Eligible participants allocated to the pembrolizumab first course in Cohort 1 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.	Cohort 2 (Second Course) n=7 participants at risk Eligible participants allocated to the pembrolizumab first course in Cohort 2 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year.	Cohort 3 (Second Course) n=3 participants at risk Eligible participants allocated to the pembrolizumab first course in Cohort 3 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year.
Blood and lymphatic system disorders Anaemia	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Myocardial infarction	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Myocarditis	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Pericarditis	2.9% 2/69 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Stress cardiomyopathy	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Alcoholic pancreatitis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Diarrhoea	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Hyperthermia	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Pyrexia	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Autoimmune hepatitis	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Immune system disorders Acute graft versus host disease	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Immune system disorders Cytokine release syndrome	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Acute sinusitis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Bronchitis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Clostridium difficile colitis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Cystitis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Device related infection	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Escherichia bacteraemia	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Gastroenteritis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Gastroenteritis salmonella	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Herpes simplex	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Herpes zoster	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Influenza	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Lower respiratory tract infection	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Myelitis	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia	5.8% 4/69 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Post procedural infection	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Respiratory tract infection	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Septic shock	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Upper respiratory tract infection	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Urosepsis	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Varicella zoster virus infection	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Hip fracture	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood creatine phosphokinase increased	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Necrotising myositis	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Epilepsy	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Polyneuropathy	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Psychiatric disorders Schizophrenia	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Acute kidney injury	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Aortic stenosis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.

Other adverse events

Other adverse events
Measure	Cohort 1 (First Course) n=69 participants at risk Participants with RRcHL who failed to achieve a response or progressed after auto-stem cell transplant (SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 2 (First Course) n=81 participants at risk Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.	Cohort 3 (First Course) n=60 participants at risk Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.	Cohort 1 (Second Course) n=10 participants at risk Eligible participants allocated to the pembrolizumab first course in Cohort 1 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.	Cohort 2 (Second Course) n=7 participants at risk Eligible participants allocated to the pembrolizumab first course in Cohort 2 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year.	Cohort 3 (Second Course) n=3 participants at risk Eligible participants allocated to the pembrolizumab first course in Cohort 3 who stopped (or completed) initial treatment with pembrolizumab after attaining confirmed CR, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 Q3W for up to 17 cycles up to approximately an additional year.
Blood and lymphatic system disorders Anaemia	10.1% 7/69 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	9.9% 8/81 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Blood and lymphatic system disorders Neutropenia	7.2% 5/69 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.7% 4/60 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Blood and lymphatic system disorders Thrombocytopenia	5.8% 4/69 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.7% 3/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Palpitations	5.8% 4/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Malaise	5.8% 4/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Pericarditis	2.9% 2/69 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Ear and labyrinth disorders Ear congestion	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Ear and labyrinth disorders Ear pain	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Endocrine disorders Hypothyroidism	11.6% 8/69 • Number of events 9 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	16.0% 13/81 • Number of events 14 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 12/60 • Number of events 15 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Eye disorders Iritis	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Eye disorders Scleral hyperaemia	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Eye disorders Visual impairment	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal discomfort	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal pain	7.2% 5/69 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 5/81 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal pain upper	4.3% 3/69 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.7% 3/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Constipation	13.0% 9/69 • Number of events 12 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.6% 11/81 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 23 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Diarrhoea	29.0% 20/69 • Number of events 37 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.8% 12/81 • Number of events 19 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	18.3% 11/60 • Number of events 17 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 2/10 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	57.1% 4/7 • Number of events 7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	66.7% 2/3 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Dyspepsia	2.9% 2/69 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.7% 4/60 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Nausea	23.2% 16/69 • Number of events 25 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.6% 11/81 • Number of events 15 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	18.3% 11/60 • Number of events 32 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Stomatitis	5.8% 4/69 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Vomiting	23.2% 16/69 • Number of events 22 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.1% 9/81 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	21.7% 13/60 • Number of events 20 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Asthenia	8.7% 6/69 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.1% 9/81 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Catheter site erosion	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Chest discomfort	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Chest pain	4.3% 3/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Chills	5.8% 4/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 5/81 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Fatigue	21.7% 15/69 • Number of events 16 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	21.0% 17/81 • Number of events 19 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	26.7% 16/60 • Number of events 19 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	30.0% 3/10 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Influenza like illness	10.1% 7/69 • Number of events 9 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Oedema peripheral	4.3% 3/69 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Pain	4.3% 3/69 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Pyrexia	39.1% 27/69 • Number of events 48 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	22.2% 18/81 • Number of events 22 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	26.7% 16/60 • Number of events 17 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	40.0% 4/10 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Immune system disorders Sarcoidosis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Bronchitis	8.7% 6/69 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.7% 7/60 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Conjunctivitis	5.8% 4/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Folliculitis	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Gastroenteritis	4.3% 3/69 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Herpes zoster	2.9% 2/69 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.7% 4/60 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Nasopharyngitis	17.4% 12/69 • Number of events 15 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	19.8% 16/81 • Number of events 16 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.7% 7/60 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 2/10 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia	7.2% 5/69 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 5/81 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Respiratory tract infection	7.2% 5/69 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.7% 3/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Respiratory tract infection viral	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Rhinitis	11.6% 8/69 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Sinusitis	10.1% 7/69 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.1% 9/81 • Number of events 12 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 9 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Upper respiratory tract infection	33.3% 23/69 • Number of events 33 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.6% 7/81 • Number of events 7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 12/60 • Number of events 22 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 2/10 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Urinary tract infection	5.8% 4/69 • Number of events 10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.4% 6/81 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	100.0% 3/3 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Fall	4.3% 3/69 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Infusion related reaction	8.7% 6/69 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Limb injury	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Alanine aminotransferase increased	10.1% 7/69 • Number of events 12 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.7% 3/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Aspartate aminotransferase increased	8.7% 6/69 • Number of events 12 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.7% 3/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood alkaline phosphatase increased	7.2% 5/69 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood creatinine increased	5.8% 4/69 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 2/10 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood thyroid stimulating hormone increased	2.9% 2/69 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood uric acid increased	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Platelet count decreased	4.3% 3/69 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.7% 3/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Weight increased	4.3% 3/69 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 5/81 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Decreased appetite	4.3% 3/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.4% 6/81 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hyperuricaemia	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypocalcaemia	4.3% 3/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypokalaemia	7.2% 5/69 • Number of events 7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 5/81 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypomagnesaemia	2.9% 2/69 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypophosphataemia	2.9% 2/69 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 2/10 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Arthralgia	20.3% 14/69 • Number of events 20 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.8% 12/81 • Number of events 14 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 6/60 • Number of events 10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Back pain	11.6% 8/69 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.8% 12/81 • Number of events 13 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	30.0% 3/10 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Muscle spasms	11.6% 8/69 • Number of events 12 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Muscular weakness	5.8% 4/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Myalgia	8.7% 6/69 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 5/81 • Number of events 7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 5/60 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Pain in extremity	5.8% 4/69 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour inflammation	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Disturbance in attention	5.8% 4/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Headache	17.4% 12/69 • Number of events 19 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.4% 6/81 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	16.7% 10/60 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 2/10 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Neuropathy peripheral	4.3% 3/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 5/81 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Peripheral sensory neuropathy	5.8% 4/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Psychiatric disorders Anxiety	4.3% 3/69 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.7% 4/60 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Psychiatric disorders Depression	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.7% 3/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Psychiatric disorders Insomnia	10.1% 7/69 • Number of events 7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.4% 6/81 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.7% 7/60 • Number of events 7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Erythema	5.8% 4/69 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.5% 2/81 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Haematuria	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Reproductive system and breast disorders Pelvic pain	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Cough	27.5% 19/69 • Number of events 26 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	27.2% 22/81 • Number of events 37 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	23.3% 14/60 • Number of events 19 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	20.0% 2/10 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	28.6% 2/7 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.6% 8/69 • Number of events 19 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	12.3% 10/81 • Number of events 16 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.7% 7/60 • Number of events 13 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.7% 6/69 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	9.9% 8/81 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.3% 8/60 • Number of events 14 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.1% 7/69 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.6% 7/81 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	15.0% 9/60 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Productive cough	14.5% 10/69 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.7% 4/60 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	13.0% 9/69 • Number of events 10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.9% 4/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Tonsillar exudate	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Alopecia	4.3% 3/69 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.7% 4/60 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Dry skin	7.2% 5/69 • Number of events 6 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 5/81 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 2/60 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Pruritus	17.4% 12/69 • Number of events 16 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.6% 11/81 • Number of events 18 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.7% 7/60 • Number of events 8 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	30.0% 3/10 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Rash	17.4% 12/69 • Number of events 15 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.1% 9/81 • Number of events 11 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	16.7% 10/60 • Number of events 14 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 1/7 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/69 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 4 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.7% 4/60 • Number of events 5 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Rash pruritic	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/81 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/60 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Hot flush	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 1/81 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 3/60 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/7 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.3% 1/3 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Hypertension	1.4% 1/69 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.7% 3/81 • Number of events 3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 1/60 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	28.6% 2/7 • Number of events 2 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/3 • Up to approximately 99 months. The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received at least 1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER